FDA Oncology News: April 2026 Approvals, NDAs, and Priority Reviews

The past month saw significant regulatory activity across solid tumors and hematologic malignancies, including a transition to full approval for a chimeric antigen receptor (CAR) T-cell therapy, several new drug application (NDA) acceptances for targeted agents, and review extensions for highly anticipated delivery methods and cell therapies. Here are the top happenings from the FDA in oncology in April 2026.

Hematologic Malignancies

Full Approval: Brexucabtagene Autoleucel in R/R Mantle Cell Lymphoma

The FDA granted full approval to the CAR T-cell therapy brexucabtagene autoleucel (brexu-cel; Tecartus) for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL). This conversion from accelerated approval is supported by long-term follow-up data from the ZUMA-2 trial (NCT02601313), confirming the durable efficacy and safety profile of the agent in this patient population.

Review Extension: Orca-T for MDS and Leukemia

The FDA has extended the Prescription Drug User Fee Act (PDUFA) goal date for the NDA of Orca-T, a high-precision cell therapy being investigated for patients with myelodysplastic syndromes (MDS) and acute leukemias. The extension allows the agency additional time to review supplementary data provided during the application process. Orca-T aims to reduce graft-vs-host disease (GVHD) while maintaining graft-vs-leukemia effects.

Review Extension: Subcutaneous Isatuximab in Multiple Myeloma

The review period for the subcutaneous (SC) formulation of the CD38-directed antibody isatuximab (Sarclisa) has been extended. The FDA requested additional information regarding the delivery device and manufacturing process. If approved, the SC administration—delivered via an on-body injector—is expected to significantly reduce treatment burden compared to the current intravenous infusion.

Thoracic Oncology

Priority Review: Ifinatamab Deruxtecan in Advanced SCLC

The FDA has granted priority review to the B7-H3–directed antibody-drug conjugate (ADC) ifinatamab deruxtecan (I-DXd) for patients with advanced small cell lung cancer (SCLC). The application is supported by the IDeate-Lung01 trial (NCT05280470), which demonstrated robust objective response rates in patients who had progressed on or after platinum-based chemotherapy.

NDA Acceptance: Zipalertinib in EGFR Exon 20 Mutant NSCLC

The FDA has accepted the NDA for zipalertinib, a selective EGFR tyrosine kinase inhibitor (TKI), for the treatment of patients with non–small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations. This represents a potential new targeted option for a molecular subset that has historically been difficult to treat with traditional TKIs.

NDA Submission: Neladalkib in Advanced ALK+ NSCLC

An NDA has been submitted for neladalkib, a potent, brain-penetrant fourth-generation ALK TKI. The submission targets patients with advanced ALK-positive NSCLC, including those who have progressed on prior ALK inhibitors. Early data suggests high intracranial activity, addressing a critical need for patients with central nervous system (CNS) metastases.

Gastrointestinal and Hepatobiliary Cancers

Priority Review: Zanidatamab in HER2+ Gastroesophageal Adenocarcinoma

Zanidatamab, a HER2-targeted bispecific antibody, has been granted priority review for use in combination with chemotherapy as a first-line treatment for patients with HER2-positive gastroesophageal adenocarcinoma (GEA). The application is based on the HERIZON-GEA-01 trial (NCT05152147), which showed improved progression-free survival compared with the standard of care.

BLA Filing: Zenocutuzumab in NRG1+ Cholangiocarcinoma

A biologics license application (BLA) has been filed for zenocutuzumab, a HER2/HER3 bispecific antibody, specifically for the treatment of neuregulin 1 (NRG1) fusion-positive cholangiocarcinoma. This follows clinical data showing zenocutuzumab can effectively inhibit the signaling pathway driven by NRG1 fusions across multiple tumor types.

Neuro-Oncology and Melanoma

NDA Acceptance: 18F-FET PET Imaging Agent in Glioma

The FDA has accepted the NDA for 18F-FET (O-(2-[18F]fluoroethyl)-L-tyrosine), a radiopharmaceutical for PET imaging in the management of glioma. Unlike standard glucose-based PET, 18F-FET provides better visualization of tumor extent and differentiation between tumor recurrence and radiation-induced changes (pseudoprogression).

Second CRL: RP1 Plus Nivolumab in Advanced Melanoma

The FDA issued a second complete response letter (CRL) regarding the application for RP1 (vusolimogene oderparepvec), an oncolytic immunotherapy, in combination with nivolumab (Opdivo) for patients with advanced melanoma. The agency’s concerns reportedly relate to the need for additional clinical data or manufacturing clarifications rather than immediate safety signals.