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.
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