Submission of a new drug application for zipalertinib plus chemotherapy has begun under the FDA's RTOR program, based on phase 3 REZILIENT3 data showing a 6-month PFS gain.
October 2026 Brief
FDA expands pirtobrutinib into first-line CLL/SLL for adults without 17p deletion, delivering major PFS gains versus bendamustine-rituximab.
TRE-515 could improve the durability of response in combination with KRAS inhibition in patients with advanced non–small cell lung cancer, investigators stated.
The FDA approved tucatinib with trastuzumab and pertuzumab as maintenance therapy in HER2-positive breast cancer, based on median PFS of 24.9 vs 16.3 months in HER2CLIMB-05.
FDA grants 2 breakthrough therapy designations to Temab-A, speeding development for hard-to-treat colorectal cancer and c-Met–expressing lung cancer.
The approval of the adjuvant atezolizumab combination in dMMR colon cancer is supported by the phase 3 ATOMIC trial.
VIR-5500 and [²¹²Pb]PSV359 received FDA fast track designations for prostate cancer and solitary fibrous tumors, respectively.
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