Oncologists discuss long-term ibrutinib use, cardiovascular risks with BTK inhibitors, and emerging fixed-duration acalabrutinib-venetoclax therapy in CLL.
News|Articles|June 5, 2026
May 2026: FDA Oncology Actions at a Glance
Author(s)Targeted Oncology Staff
Fact checked by: Sabrina Serani
FDA greenlights eight May 2026 oncology approvals, debuting first PROTAC, expanding breast ADCs, and advancing biomarker-driven bladder cancer and rare blood cancers.
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May 2026 proved to be one of the most consequential months of the year for oncology regulators, with the FDA issuing 8 oncology and hematology approvals spanning breast cancer, bladder cancer, hematologic malignancies, and rare solid tumors. The month opened with a historic milestone—the first-ever FDA approval of a PROTAC (proteolysis-targeting chimera) in any indication—and closed with a novel antibody-drug conjugate for an ultra-rare blood cancer. Below is a glance at every key action from the month.
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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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