Hyrnuo (sevabertinib)Treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy11/19/20254933-1: Complete the ongoing multicenter, randomized clinical trial, Study SOHO-02, intended to verify and describe the clinical benefit of sevabertinib in adult patients with locally advanced or metastatic non-squamous NSCLC whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations and who have not received prior therapy for advanced disease.10/31/2029 Hernexeos (zongertinib)Treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA approved test, and who have received prior systemic therapy8/8/20254881-1: Complete the ongoing multicenter, randomized clinical trial, Study Beamion LUNG-2, intended to verify and describe the clinical benefit of zongertinib in adult patients with advanced, unresectable or metastatic non-squamous non-small cell lung cancer whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations.11/30/2029 Modeyso (dordaviprone)Treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.8/6/20254861-1: Complete a multiregional, randomized clinical trial in patients with H3 K27M-mutant diffuse midline glioma, intended to verify and describe the clinical benefit of dordaviprone through assessment of overall survival (OS) as a primary endpoint. 4861-2: Conduct a clinical trial in pediatric patients (<17 years of age) with H3 K27M-mutant diffuse midline glioma, inclusive of a sufficient number of patients with Diffuse Intrinsic Pontine Glioma (DIPG), intended to verify and describe the clinical benefit of dordaviprone in the pediatric population. Endpoints evaluated should include overall response rate (ORR), duration of response (DOR), and overall survival (OS).7/31/2031 Zegfrovy (sunvozertinib)Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test7/2/20254867-1 Conduct a multicenter, randomized clinical trial intended to verify and describe the clinical benefit of sunvozertinib in patients with locally advanced, unresectable or metastatic non-small cell lung cancer whose tumors have EGFR exon 20 insertion mutations. The final analysis should include the final progression-free survival and overall survival results. This data may be obtained from the ongoing clinical trial, entitled, DZ2022E0005 (WU-KONG28), “A Phase 3, Open-Label, Randomized, Multi-Center Study of DZD9008 versus Platinum-Based Doublet Chemotherapy as First-Line Treatment for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Exon 20 Insertion Mutation.”7/31/2026 Lynozyfic (linvoseltamab-gcpt)Treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.7/2/20254848-1: Complete a randomized clinical trial in patients with relapsed or refractory multiple myeloma. Patients should be randomized to receive linvoseltamab compared to standard therapy for relapsed or refractory multiple myeloma. The primary endpoint should be progression-free survival and key secondary endpoints should include overall response rate and overall survival. The trial should enroll a sufficiently representative study population to allow for generalizability of the result to the U.S. patient population with multiple myeloma.6/30/2027 Datroway (datopotamab deruxtecan-dlnk)Treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy.6/23/20254860-1: Conduct a multicenter, randomized clinical trial, TROPION-LUNG15, intended to verify and describe the clinical benefit of datopotamab deruxtecan in patients with EGFR-mutated non-small cell lung cancer who have had disease progression after osimertinib.11/30/2029 Emrelis (telisotuzumab vedotin-tllv)Treatment of adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test, who have received a prior systemic therapy.5/14/20254844-1: Complete the ongoing randomized trial, Study M18-868, intended to verify and describe the clinical benefit of telisotuzumab vedotin in patients with previously treated c-Met overexpressing, EGFR wildtype, locally advanced/metastatic non-squamous non-small cell lung cancer.6/30/2029 Avmapki Fakzynja Co-Pack (avutometinib capsules; defactinib tablets)Treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy5/8/20254835-1: Complete the ongoing trial titled, “RAMP 301: A Phase 3, Randomized, Open-Label Study of Combination Therapy with Avutometinib plus Defactinib Versus Investigator’s Choice of Treatment in Patients with Recurrent Low-Grade Serous Ovarian Cancer (LGSOC)”, and provide the progression-free survival and the final overall survival analyses, intended to describe and verify the clinical benefit of avutometinib and defactinib in combination in adult patients with recurrent, KRAS-mutated low grade serous ovarian cancer. Include central KRAS testing results for all patients.6/30/2028 Breyanzi (lisocabtagene maraleucel)Adult patients with relapsed/ refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in patients who have received at least two prior lines of therapy including a Bruton’s tyrosine kinase (BTK) inhibitor and a B-cell lymphoma-2 (BCL-2) inhibitor 3/21/20241- Conduct a single arm study of lisocabtagene maraleucel in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least 2 prior lines of therapy, including a prior Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor, to evaluate overall response rate and durability. The study must include a total of 50 treated patients and durable response should be based on a minimum follow-up of 15 months after first objective disease response. 5/31/2027 Braftovi (encorafenib)In combination with cetuximab and mFOLFOX6, for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test12/20/20244753-1: Conduct a randomized comparative clinical trial intended to verify and describe the clinical benefit of encorafenib and cetuximab in combination with mFOLFOX6 in adult patients with previously untreated BRAF V600E mutation-positive metastatic colorectal cancer by assessing progression free survival. This data may be obtained from the ongoing clinical trial, BREAKWATER (C4221015), “An open-label, multicenter, randomized Phase 3 study of EC alone (EC Arm) or in combination with chemotherapy (mFOLFOX6; EC + mFOLFOX6 Arm) versus standard-of-care chemotherapies (Control Arm: mFOLFOX6, FOLFOXIRI, or CAPOX each with or without bevacizumab) in first-line participants With BRAF V600E- mutant mCRC".5/31/2025 Bizengri (zenocutuzumab-zbco)Treatment of adults with advanced unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.12/4/20244727-2: Complete a clinical trial intended to verify and describe the clinical benefit of zenocutuzumab 750 mg intravenously every two weeks in at least 50 evaluable adult patients with advanced unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy (or who are not eligible for standard of care therapy). To characterize response rate and duration, patients will be followed for at least 12 months from the onset of response.8/31/2026 Bizengri (zenocutuzumab-zbco)Treatment of adults with advanced unresectable or metastatic nonsmall cell lung cancer (NSCLC) harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.12/4/20244727-1: Complete a clinical trial intended to verify and describe the clinical benefit of zenocutuzumab 750 mg intravenously every two weeks in at least 100 evaluable adult patients with advanced unresectable or metastatic NSCLC harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy. To characterize response rate and duration, patients will be followed for at least 12 months from the onset of response.8/31/2026 Ziihera (zanidatamab-hrii)Treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test11/20/20244732-1: Complete the ongoing randomized clinical trial, Study JZP598-302, entitled, “An Open-Label Randomized Trial of the Efficacy and Safety of Zanidatamab with Standard-of-Care Therapy Against Standard-of-Care Therapy Alone for Advanced HER2-Positive Biliary Tract Cancer”, intended to verify and describe the clinical benefit of zanidatamab for patients with HER2-positive (IHC3+), unresectable or metastatic biliary tract cancer. The trial should compare zanidatamab in combination with the standard of care in patients with HER2-positive (IHC3+), unresectable or metastatic biliary tract cancer.9/30/2029 Scemblix (asciminib)Treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).10/29/20244724-1:Complete clinical study CABL001J12301 (ASC4FIRST), A Phase 3, Multi-center, Open-label, Randomized Study of Oral Asciminib versus Investigator Selected TKI in Patients with Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase, intended to describe and confirm the clinical benefit of asciminib to include at least 60 months follow-up of all patients.6/30/2028 Tecelra (afamitresgene autoleucel)Treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices.8/2/20241: Submit the Final Clinical Study Report, including datasets from ADP-0044-002 Cohorts 2 and 3, to verify and describe the clinical benefit of afamitresgene autoleucel, through more precise estimation of the overall response rate and mature response duration per independent review assessment, in adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive, and whose tumor expresses the MAGE-A4 tumor antigen as determined by FDA-approved or cleared companion diagnostic devices. Overall response rate and duration of response will be assessed by independent review and all patients will be followed for at least 15 months to assess duration of response.12/31/2025 Krazati (adagrasib)In combination with cetuximab for the treatment of adult patients with KRAS G12C mutated locally advanced or metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.6/21/20244650-1: Complete clinical trial, Study 849-010, “A Randomized Phase 3 Study of adagrasib 600 mg twice daily in combination with cetuximab versus chemotherapy in patients with advanced colorectal cancer with KRAS G12C mutation with disease progression on or after first-line therapy.”9/30/2027 Augtyro (repotrectinib)Treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, are locally advanced or metastatic where surgical resection is likely results in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy6/13/20244649-1: Conduct an analysis of patients from ongoing or planned trials to verify and describe the clinical benefit of repotrectinib through more precise estimation of the overall response rate and mature response duration per independent review assessment, in adult and pediatric patients 12 years of age and older with solid tumors with a neurotrophic receptor tyrosine kinase (NTRK) gene fusion who have locally advanced or metastatic disease or would require surgical resection that would result in severe morbidity; and have no satisfactory alternative treatment or that have progressed following treatment. A sufficient number of patients will be evaluated to more precisely characterize response and durability of response for a spectrum of patients with different TKI-naïve and TKI-pretreated tumor types. All responding patients will be followed for at least 12 months from the onset of response or until disease progression whichever comes first.5/31/2030 Breyanzi (lisocabtagene maraleucel)Adult patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy5/15/20241- Collect and submit the final report, including datasets from the TRANSCEND FL clinical trial (NCT04245839) to verify and describe the clinical benefit of lisocabtagene maraleucel (BREYANZI) in adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy (including an anti-CD20 antibody and an alkylating agent). All partial and complete responders should have completed at least 24 months of follow up starting from the initial objective response.8/31/2025 Ojemda (tovorafenib)Patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.4/23/20244608-1: Conduct a multiregional, randomized clinical trial comparing tovorafenib to physician’s choice of chemotherapy in pediatric patients with low grade glioma with RAF fusions or rearrangements, or V600 mutations, intended to verify and describe the clinical benefit of tovorafenib through assessment of overall response rate (ORR) as a primary endpoint and progression-free survival (PFS) and duration of response, as determined by blinded independent central review, as key secondary endpoints. Include the protocol-specified ORR and interim PFS analyses in the interim report.4/30/2032 Enhertu (fam-trastuzumab deruxtecan-nxki)Adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.4/5/20244624-1: Complete Cohort A in Part 2 of the ongoing DESTINY-PanTumor02 trial intended to verify and describe the clinical benefit of Enhertu in adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors that have progressed following prior treatment and have no satisfactory alternative treatment options. Include a minimum of 40 patients across all tumor types, other than breast, colorectal, lung, and gastric/GEJ cancer, including a sufficient number of patients with and representation of HER2-positive (IHC3+) tumor types that require additional characterization. In order to characterize response rate and duration of response, patients should be followed for at least 12 months from the onset of response.6/30/2027 Iclusig (ponatinib)Adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy.3/19/20244593-1: Complete the randomized trial Ponatinib-3001 (PhALLCON) intended to verify and describe the clinical benefit of ponatinib in adults with newly diagnosed Ph+ acute lymphoblastic leukemia.6/30/2028 Brukinsa (zanubrutinib)Adult patients with relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy3/7/20244583-1: Complete a randomized clinical trial that evaluates the clinical benefit of zanubrutinib plus obinutuzumab versus lenalidomide plus rituximab in patients with relapsed or refractory FL. The primary endpoint should be PFS, with secondary endpoints that include ORR and OS. The trial should enroll a sufficiently representative study population that reflects the racial and ethnic diversity of the U.S. population of patients with FL and that allows for interpretation of the results in these populations.1/31/2029 Amtagvi (lifileucel)Adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.2/16/20241: Complete the Phase 3, multiregional, multicenter, randomized, open-label controlled trial (IOV-MEL-301) in patients with previously untreated unresectable or metastatic melanoma. Patients will be randomized to lifileucel (LN-144) regimen in combination with pembrolizumab or to pembrolizumab monotherapy. The dual primary endpoints will be ORR and PFS, with OS as the key secondary endpoint.3/31/2031 Elrexfio (elranatamab-bcmm)Adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.8/14/20234476-1: Complete a randomized clinical trial in patients with relapsed or refractory multiple myeloma. Patients should be randomized to receive an elranatamab-based regimen compared to standard therapy for relapsed or refractory multiple myeloma. The primary endpoint should be progression-free survival and secondary endpoints should include overall survival and overall response rate. The trial should enroll sufficient numbers of older patients (ages 65-74 years and 75 years and above) to enable an evaluation of elranatamab in a study population that reflects the age of the U.S. population of patients with multiple myeloma.9/30/2026 Talvey (talquetamab-tgvs)Adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody8/9/20234473-1: Conduct a randomized clinical trial that evaluates the clinical efficacy and safety of talquetamab in patients with relapsed or refractory multiple myeloma. Patients should be randomized to receive a talquetamab-based regimen compared to standard therapy for relapsed or refractory multiple myeloma. The primary endpoint should be progression-free survival and secondary endpoints should include overall survival and overall response rate. The trial should enroll sufficient numbers of racial and ethnic minority patients and older patients (ages 65-74 years and 75 years and above) to enable an evaluation of talquetamab in a study population that reflects the U.S. population of patients with multiple myeloma.12/31/2026 Columvi (glofitamab-gxbm)Relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified or large B-cell lymphoma arising from follicular lymphoma, after two or more lines of systemic therapy6/15/20234464-1 Complete a randomized clinical trial that evaluates the clinical benefit of glofitamab in patients with diffuse large B-cell lymphoma. The trial should compare glofitamab in combination with gemcitabine and oxaliplatin (GemOx) to rituximab in combination with GemOx for patients with relapsed or refractory diffuse large B-cell lymphoma. The primary endpoint should be overall survival with secondary endpoints that include progression-free survival and response rate.9/30/2024 Epkinly (epcoritamab-bysp)Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy.5/19/20234435-1: Complete a randomized clinical trial in patients with relapsed or refractory large B-cell lymphoma. The trial should compare epcoritamab monotherapy to an investigator’s choice of standard therapies for patients with relapsed or refractory large B-cell lymphoma. The primary endpoint should be OS with secondary endpoints that include PFS and response rate.6/30/2025 Zynyz (retifanlimab-dlwr)Adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC).3/22/20234412-1: Conduct a multicenter clinical trial intended to confirm the clinical benefit of retifanlimab-dlwr in patients with metastatic or recurrent locally advanced MCC who have not received prior systemic therapies for metastatic or recurrent locally advanced MCC. The trial will enroll at least 100 patients to be followed for a minimum of 12 months to establish the ORR and characterize the DOR. Include an analysis of OS, when 70% of patients have died, or all patients have been followed for at least three years.3/31/2025 Jaypirca (pirtobrutinib)Adult patients with relapsed or refractory mantle cel lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor.1/27/20234389-1: Complete a randomized clinical trial to obtain data on the clinical efficacy and safety of pirtobrutinib in patients with MCL. The trial should compare pirtobrutinib monotherapy to an investigator’s choice of approved BTK inhibitors in patients with MCL. The primary endpoint should be PFS as assessed by an independent review committee, with secondary endpoints that include OS and objective response rate. The trial should enroll a sufficiently representative study population to reflect the racial and ethnic diversity of the U.S. patient population with MCL and allow for interpretation of the results in these patient populations.12/31/2026 Tukysa (tucatinib)In combination with trastuzumab for the treatment of adult patients with RAS wild-type, HER2-positive, unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy1/19/20234388-1: Conduct a randomized clinical trial to obtain data on the clinical efficacy of tucatinib for patients with RAS wild type, HER2-positive, unresectable or metastatic colorectal carcinoma. The trial should compare tucatinib in combination with trastuzumab with the standard of care in patients with RAS wild type, HER2-positive, unresectable or metastatic colorectal carcinoma. The primary endpoint should be PFS per blinded assessment or OS. The trial should enroll a sufficiently representative study population to reflect the racial and ethnic diversity of the U.S. patient population with RAS wild type, HER2-positive, unresectable or metastatic colorectal carcinoma and allow for interpretation of the results across this representative study population.04/30/2026 Lunsumio (mosunetuzumab-axgb)Adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.12/22/20224375-1: Conduct a randomized clinical trial in patients with relapsed or refractory follicular lymphoma (FL), with patients randomized to receive mosunetuzumab in combination with lenalidomide or rituximab in combination with lenalidomide. The primary endpoint should be PFS, with secondary endpoints that include RR and OS. The trial should enroll a sufficiently representative study population to reflect the racial and ethnic diversity of the U.S. patient population with FL and allow for interpretation of the results in these patient populations.12/31/2025 Krazati (adagrasib)Adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy.12/12/20224378-1: Conduct a randomized comparative clinical trial of adagrasib in adult patients with KRAS G12C mutated, locally advanced or metastatic NSCLC who have received at least one prior systemic therapy, to obtain OS, PFS, ORR, and DOR. This data may be obtained from the ongoing clinical trial entitled, “A Randomized Phase 3 Study of MRTX849 versus Docetaxel in Patients with Previously Treated Non-Small Cell Lung Cancer with KRAS G12C Mutation.”12/31/2025 Tecvayli (teclistamab-cqyv)Adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody10/25/20224334-1: Conduct a randomized clinical trial in patients with relapsed or refractory multiple myeloma. The trial should enroll sufficient numbers of racial and ethnic minority patients and older patients (ages 65-74 and 75 and above) to enable an evaluation of teclistamab in a study population that better reflects the U.S. population of patients with multiple myeloma. Patients should be randomized to receive a teclistamab-based regimen compared to standard therapy for relapsed or refractory multiple myeloma. The primary endpoint should be PFS and secondary endpoints should include OS, ORR, and DOR.3/31/2026 Lytgobi (futibatinib)Adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements9/30/20224345-1: Conduct a randomized clinical trial comparing dosages of futibatinib 16 mg and 20 mg once daily to verify and describe the clinical benefit of futibatinib in patients with advanced or metastatic cholangiocarcinoma harboring an FGFR2 gene fusion or other rearrangement. The ORR and DOR should be assessed by a blinded independent review. The study should also evaluate other clinical outcomes that denote clinical benefit, such as PROs. This study should enroll a minimum of 120 patients and all responders should have a minimum of 6 months from the date of initial response (or until disease progression, whichever comes first). Ensure that racial and ethnic minorities are adequately represented in the trial population, at a minimum, proportional to the prevalence of FGFR2 alterations in these subgroups in the US population.10/31/2027 Retevmo (selpercatinib)Adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options *9/21/20224342-1: Complete clinical trial(s) to obtain data on the clinical efficacy of selpercatinib through more precise estimation of the ORR and mature response duration per independent review assessment, in at least 60 patients with locally advanced or metastatic RET-fusion positive solid tumors other than NSCLC and thyroid cancer, who have progressed on prior systemic treatment or have no satisfactory alternative treatment options. A sufficient number of patients with tumor types for which responses require additional characterization (e.g., colorectal cancer, esophagogastric cancer, and glioma) will be evaluated. ORR and DOR will be assessed by independent central review and all responding patients will be followed for at least 12 months following the onset of response or until disease progression or death or early treatment discontinuation, whichever comes first. Include available data regarding RET fusion partners and co-occurring genetic alterations for all patients.12/31/2025 Enhertu (Fam-trastuzumab deruxtecan-nxki)Adult patients with unresectable or metastatic NSCLC whose tumors have an activating HER2 (ERBB2) mutation, as detected by an FDA-approved test, and who have received a prior systemic therapy8/11/2022

4321-1: Complete a clinical trial to obtain data on the clinical efficacy of fam-trastuzumab deruxtecan-nxki for the treatment of patients with unresectable or metastatic NSCLC whose tumors have an activating HER2 (ERBB2) mutation and have previously received systemic therapy, to provide a more precise estimation of the BICR-assessed ORR and DOR. This report will contain data from patients with NSCLC harboring HER2 mutations and data from at least 102 patients who have received prior systemic therapy, after all responders have been followed for at least 6 months from the date of initial response (or until disease progression, whichever comes first).

4321-2: Conduct a multicenter, randomized clinical trial of fam-trastuzumab deruxtecan-nxki in patients with treatment-naïve, unresectable or metastatic NSCLC whose tumors have an activating HER2 (ERBB2) mutation. The final analysis should include the final PFS and OS results.

3/31/2024 Tafinlar (dabrafenib)In combination with trametinib for adult and pediatric patients 6 years of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. *6/22/20224298-1: Conduct a clinical trial(s) in at least 80 patients with solid tumors with a BRAF V600E mutation to verify and describe the clinical benefit of dabrafenib in combination with trametinib, through more precise estimation of the ORR and mature response duration. Include patients with unresectable or metastatic solid tumors with a BRAF V600E mutation from the ongoing trial and from a prospectively conducted trial (which will exclude patients with melanoma, non-small cell lung cancer, anaplastic thyroid cancer, biliary tract cancer, gliomas and colorectal cancer). Follow all patients for at least 6 months from the onset of response to characterize the response rate and duration.10/31/2028 Mekinist (trametinib)In combination with dabrafenib for adult and pediatric patients 6 years of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options *6/22/20224297-1: Conduct a clinical trial(s) in at least 80 patients with solid tumors with a BRAF V600E mutation to verify and describe the clinical benefit of trametinib in combination with dabrafenib, through more precise estimation of the ORR and mature response duration. Include patients with unresectable or metastatic solid tumors with a BRAF V600E mutation from the ongoing trial and from a prospectively conducted trial (which will exclude patients with melanoma, non-small cell lung cancer, anaplastic thyroid cancer, biliary tract cancer, gliomas and colorectal cancer). Follow all patients for at least 6 months from the onset of response to characterize the response rate and duration.10/31/2028 Kymriah (tisagenlecleucel)Treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy5/27/2022Conduct a randomized phase 3 trial in adult patients with r/r FL. Patients will be randomized to tisagenlecleucel or an investigator’s choice of regimens consistent with the standard of care. The primary endpoint will be PFS with secondary endpoints that include OS and ORR.9/30/2028 Vijoice (alpelisib)Treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy4/5/20224260-1: Conduct a multiregional clinical trial to verify and describe the clinical benefit of alpelisib film-coated tablets, through more precise estimation of confirmed ORR and mature response duration per blinded independent review, in adult and pediatric patients 2 years of age and older with PROS, including those with severe manifestations. Responding patients will be followed for at least 36 months from the onset of response, or until disease progression, whichever comes first. Evaluate a sufficient number of patients to characterize response rate and durability of response by PIK3CA mutation type, PROS subtype, and age.8/31/2027 Gavreto (pralsetinib)Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate)12/1/20203959-2: Submit the final report of integrated studies and datasets, to verify and further characterize the clinical benefit of pralsetinib for the treatment of patients with RET fusion-positive thyroid cancer who have received radioactive iodine (if appropriate for their tumor histology) to provide a more precise estimation of the BICR-assessed ORR and DOR in at least 50 patients in a variety of histologies after all responding patients have been followed for 12 months following onset of response or until disease progression, whichever comes first.6/30/2025 Brukinsa (zanubrutinib)Treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen9/14/20214128-1: Conduct a randomized clinical trial that verifies and describes the clinical benefit of zanubrutinib in patients with relapsed or refractory MZL. The trial should include sufficient representation of racial and ethnic minorities to better reflect the U.S. patient population and allow for interpretation of the results in these patient populations. The primary endpoint should be PFS, with secondary endpoints that include ORR and OS.10/31/2028 Jemperli (dostarlimab-gxly)Treatment for adult patients with mismatch repair deficient (dMMR) recurrent or advanced solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options8/17/20214124-1: Conduct a clinical trial evaluating ORR, and DOR, to verify and describe the clinical benefit of Jemperli in patients with dMMR, recurrent or advanced solid tumors, including at least 300 patients across all tumor types, and including a sufficient number of patients and representation of tumor types (other than endometrial and GI tumors). In order to characterize response rate and DOR, patients should be followed for at least 12 months from the onset of response. Submit the datasets with final report.10/31/2022 Lumakras (sotorasib)Treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy.5/28/20214071-1: Conduct a multicenter, randomized clinical trial and submit the final PFS results that verify and describe the clinical benefit of sotorasib in patients with locally advanced or metastatic NSCLC with a history of prior systemic therapy for advanced disease and whose tumors harbor KRAS G12C mutation.7/30/2022 Zynlonta (loncastuximab tesirine-lpyl)Treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low grade lymphoma, and high-grade B-cell lymphoma.4/23/20214029-1: Conduct a randomized, phase 3 clinical trial to verify and describe the clinical benefit of loncastuximab tesirine-lpyl in patients with R/R large B-cell lymphoma. The trial should include sufficient numbers of racial and ethnic minority patients to better reflect the U.S. patient population and allow for interpretation of the results in these patient populations. Patients should be randomized to receive loncastuximab tesirine-lpyl plus immunotherapy or immunochemotherapy. The primary endpoint should be PFS , with secondary endpoints that include OS and ORR.12/31/2025 Yescarta (axicabtagene ciloleucel)Treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy3/5/20211: A randomized phase 3 trial of axicabtagene ciloleucel in patients with relapsed or refractory FL. Patients will be randomized to axicabtagene ciloleucel or to an investigator’s choice of regimens consistent with the standard of care. The primary endpoint will be PFS, with secondary endpoints that include ORR and OS.9/30/2027 Danyelza (naxitamab-gqgk)In combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy.11/25/20203950-1: Submit the final report, including datasets, from an ongoing multicenter clinical trial to verify and further characterize the clinical benefit of naxitamab for the treatment of patients with R/R neuroblastoma in combination with GM-CSF in bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy; and to provide a more precise estimation of ORR and DOR (according to the revised International Neuroblastoma Response Criteria by blinded independent review). Enroll a mi