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Government Health Agency News

FDA

Pirtobrutinib OK'd for chronic and small lymphocytic leukemia

December 6, 2023

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FDA has expanded the indications for pirtobrutinib (Jaypirica), previously approved for mantle cell lymphoma, to include adults with CLL or SLL who've received ≥2 lines of therapy, including a BTK inhibitor and BCL-2 inhibitor. Approval was based on data from the phase 1/2 BRUIN trial (N=108), which showed a 72% overall response rate.

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