Oncologists discuss long-term ibrutinib use, cardiovascular risks with BTK inhibitors, and emerging fixed-duration acalabrutinib-venetoclax therapy in CLL.
News|Articles|May 1, 2026
FDA Oncology News: April 2026 Approvals, NDAs, and Priority Reviews
Author(s)Targeted Oncology Staff
Fact checked by: Sabrina Serani
Explore the April 2026 FDA oncology roundup: full approval for brexu-cel in MCL, priority reviews for I-DXd and zanidatamab, and key lung cancer NDA news.
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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.
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The FDA has approved pimicotinib (Pimjetmi) at 50 mg once daily for adults with symptomatic tenosynovial giant cell tumor, based on the phase 3 MANEUVER study.
Updated phase 2 data showed a 60% ORR and 86% CNS ORR with frontline silevertinib in non-classical EGFR-mutant NSCLC; FDA discussion supported a phase 3 trial in 2027.
Patients with relapsed or refractory CTCL who responded to denileukin diftitox-cxdl experienced improvements in skin-related quality of life and overall well-being in Study 302.
Among patients surveyed, 92% preferred home-based treatment, while nationwide modeling projected substantial savings in oncology resources.
During a live event, Pedro Barata, MD, MSc, and participating oncologists discussed how efficacy, tolerability, and clinical evidence inform subsequent-line treatment selection for metastatic clear cell renal cell carcinoma.
Imneskibart showed promising outcomes and tolerability in patients who had previously received immune checkpoint inhibition for either melanoma or lung adenocarcinoma.
Renuka Iyer, MD, explains how NCCN is digitizing its guidelines with structured data to support AI tools, prior authorization, and point-of-care access.
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