Lilly's Jaypirca Gets CHMP Nod for 2nd Leukemia Indication in Europe

Core Viewpoint - Eli Lilly's BTK inhibitor, Jaypirca, has received a positive opinion from the European Medicines Agency's CHMP for treating relapsed or refractory chronic lymphocytic leukemia (CLL) in previously treated patients, with the decision expected from the European Commission in a couple of months [1][2]. Group 1: Regulatory Approvals - Jaypirca is already conditionally approved in the EU for adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have been previously treated with a BTK inhibitor [2]. - The approval for CLL is based on data from the phase III BRUIN CLL-321 study [1]. Group 2: Sales Performance - Jaypirca recorded $337.0 million in sales in 2024, contributing to Eli Lilly's top-line growth [5]. - The drug is also being studied for earlier lines of therapy to expand its use for CLL and MCL indications [5]. Group 3: Market Competition - Current BTK inhibitors for CLL include AbbVie/J&J's Imbruvica, AstraZeneca's Calquence, and BeiGene's Brukinsa, with Imbruvica experiencing declining sales due to rising competition [6]. - None of the existing BTK inhibitors are approved for relapsed or refractory CLL in the post-BTK inhibitor setting [6]. Group 4: Stock Performance - Eli Lilly's shares have increased by 16.2% over the past year, contrasting with a 0.9% decline in the industry [3].