Ongoing | Cancer Accelerated Approvals

This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have postmarketing requirement(s) for ongoing clinical trial(s) to verify clinical benefit. Please refer to Drugs@FDA for the latest approvals and prescribing information for specific products. Visit the verified and withdrawn AA indication pages for more information and the Postmarket Requirements and Commitments page for the status of specific requirements.

Indications may remain on this page until FDA updates product labeling or publishes a Federal Register notice regarding a change in status.

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Drug Name	Accelerated Approval (AA) Indication	AA Date	AA Post-Marketing Requirement	Original Projected Completion 1
Zeggrovy (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 test	7/2/2025	4867-1 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.	7/2/2025	4848-1: 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, 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	6/23/2025	4860-1: 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.	5/14/2025	4844-1: 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 therapy	5/8/2025	4835-1: 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
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 test	12/20/2024	4753-1: 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.	12/4/2024	4727-2: 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.	12/4/2024	4727-1: 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 test	11/20/2024	4732-1: 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).	10/29/2024	4724-1: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

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1. If multiple PMRs were required, the latest date is reported here. This date represents the original agreed-upon Final Study Report date and does not include any updated deadlines submitted by the Applicant.

2. a b The original AA indication was modified to include an expanded population.

3. The original AA indication was modified to include a restricted population