Published on 30 Jan 2023 on Zacks via Yahoo Finance

Eli Lilly (LLY) Lymphoma Candidate Pirtobrutinib Gets FDA Nod

Eli Lilly and Company LLY announced that the FDA, under an accelerated approval pathway, approved BTK inhibitor, pirtobrutinib (100 mg & 50 mg tablets) for the treatment of relapsed or refractory mantle cell lymphoma (MCL), in adult patients. The drug will be marketed by the trade name of Jaypirca and can be administered in patients who have had at least two lines of systemic therapy, including a BTK inhibitor.

The approval was based on Lilly’s global, open-label, phase I/II (BRUIN) study for multicenter evaluation of the administration of Jaypirca in adult patients with hematologic malignancies, including  MCL. The study comprised a phase I study to evaluate dose escalation, a phase Ib study to evaluate the combination component and a phase II study to expand the dosage in the patient population. The primary and secondary endpoints in each of the phases of the study were met with statistical significance in terms of safety and efficacy measured by an overall response rate of 50%, with complete response observed in 13% of the patient population. The continued approval of Jaypirca will be subject to verification and description of clear medical benefits in a confirmatory study by Lilly.

In the past year, shares of Lilly have risen 39.4% compared with the industry’s rise of 9.7%.