Eli Lilly (NYSE: LLY) has submitted a marketing approval application for pirtobrutinib, an oral, non-covalent (reversible) Bruton tyrosine kinase (BTK) inhibitor, according to the China Center for Drug Evaluation (CDE) website. The application targets adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have previously undergone BTK inhibitor treatment.
Pirtobrutinib, marketed in the U.S. under the trade name Jaypirca, received accelerated approval in January 2023, following promising results from the Phase I/II BRUIN study, which evaluated its efficacy in adults with r/r MCL in the third-line treatment setting. Earlier this week, the drug also secured conditional approval in the U.S. for treating adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least two prior therapies. Notably, Innovent Biologics Inc. (HKEX: 01801) holds priority negotiation rights for the commercialization of pirtobrutinib in mainland China, a result of their enhanced partnership established in March 2022.- Flcube.com
