On December 1, Eli Lilly announced that the FDA had approved the new indication for pirtobrutinib (Jaypirca, 100mg and 50mg tablets) for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously received at least two therapies, including a BTK inhibitor and a BCL-2 inhibitor.This approval was granted through the FDA's accelerated approval pathway, primarily based on data from the open-label, single-arm, multi-cohort, international Phase I/II BRUIN study.Efficacy was evaluated in 108 patients with CLL/SLL who were treated with pirtobrutinib, all of whom had previously received at least two therapies, including a BTK inhibitor and a BCL-2 inhibitor. Patients eligible for efficacy analysis had received a median of 5 prior lines of therapy (range: 2–11), and 77% discontinued their last BTK inhibitor due to refractory disease or progression.The results showed that patients receiving pirtobrutinib 200 mg once daily dosingOverall Response Rate (ORR)72%, MedianDuration of Response (DOR)For 12.2 months.Pirtobrutinib is the world's first and only non-covalent (reversible) BTK inhibitor to receive FDA approval. It was first approved for marketing in January this year for adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have previously received at least two lines of systemic therapy.Jacob Van Naarden, CEO of Loxo, a subsidiary of Eli Lilly, stated: "This FDA approval marks the second approval for pirtobrutinib in 2023, underscoring the significant clinical benefits of continuing to leverage the BTK pathway for patients with CLL or SLL, as demonstrated by the BRUIN study. The approvals of the first two indications represent just the beginning of the impact we hope pirtobrutinib will have on patients, and we look forward to seeing the results of the comprehensive Phase III development program across CLL, SLL, and MCL."Copyright © 2023 PHARMCUBE. All Rights Reserved.
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