Closing sessions at IMS 2026 featured MRD-guided treatment strategies, real-world CAR T-cell data, and mixed results on cilta-cel neurotoxicity prevention in myeloma.
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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Half of patients who stopped MRD-guided maintenance in GEM2014MAIN remained progression-free at 7 years, as IMS 2026 also featured DREAMM-9, MIDAS, and novel bispecific data.
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