(RTTNews) - Eli Lilly and Company (LLY) said Jaypirca is one step away from European approval after regulators issued a positive opinion supporting its use in adults with chronic lymphocytic leukemia across all lines of therapy. The recommendation brings Lilly closer to expanding access to its next-generation BTK inhibitor across the European Union.
Jaypirca's (pirtobrutinib) CHMP endorsement is backed by results from the Phase 3 BRUIN CLL-313 and BRUIN CLL-314 trials, which showed strong efficacy and tolerability in both treatment-naïve patients and those previously treated with BTK inhibitors. BRUIN CLL-313 is the first Phase 3 study to evaluate a non-covalent BTK inhibitor exclusively in newly diagnosed CLL, while BRUIN CLL-314 is the first trial to directly compare non-covalent and covalent BTK inhibitors in this setting.
Lilly noted that data demonstrate "compelling evidence" that pirtobrutinib can make a meaningful difference for patients across multiple treatment stages, highlighting its potential as a versatile option in a disease where sequencing therapies is increasingly important.
With the CHMP's positive opinion now sent to the European Commission, a final decision is expected within the next one to two months.
LLY has traded between $623.78 and $1,200.55 over the past year. The stock is currently trading at $1,194.76, up 5.86%
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