Lilly's Jaypirca recommended by CHMP for EU approval in CLL across all therapy lines
- CHMP issued a positive opinion for Jaypirca (pirtobrutinib) for adults with CLL across all lines of therapy, and the application is now referred to the European Commission with a decision expected in one to two months.
- The opinion is based on Phase 3 BRUIN CLL-313 (n=282) and BRUIN CLL-314 (n=662) data, presented at ASH 2025 and published in The Journal of Clinical Oncology.
- BRUIN CLL-313 randomized treatment‑naïve patients to pirtobrutinib (200 mg once daily) versus bendamustine+rituximab (BR); BRUIN CLL-314 randomized patients to pirtobrutinib (200 mg once daily) versus ibrutinib (420 mg once daily).
- Lilly has submitted the same data to the FDA, with a U.S. regulatory decision expected in the second half of 2026.
Regulatory status
The EMA's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending Jaypirca (pirtobrutinib) for the treatment of adults with chronic lymphocytic leukemia (CLL) across all lines of therapy and regardless of prior BTK inhibitor treatment. The application is now referred to the European Commission for a final decision, expected within one to two months.
Clinical evidence
The CHMP opinion is supported by results from two Phase 3 trials, BRUIN CLL-313 and BRUIN CLL-314, whose data were presented at the American Society of Hematology 2025 meeting and published in The Journal of Clinical Oncology.
Trial details
BRUIN CLL-313 enrolled 282 previously untreated CLL/SLL patients without 17p deletions and randomized them 1:1 to pirtobrutinib (200 mg orally once daily) or bendamustine plus rituximab (BR); its primary endpoint was blinded IRC-assessed progression-free survival (PFS). BRUIN CLL-314 enrolled 662 patients (treatment‑naïve or previously treated but BTK inhibitor‑naïve) randomized 1:1 to pirtobrutinib (200 mg once daily) or ibrutinib (420 mg once daily); its primary endpoint was blinded IRC-assessed overall response rate (ORR).
Next steps
Lilly has submitted the BRUIN CLL-313 and CLL-314 data to the U.S. Food and Drug Administration, with a decision expected in the second half of 2026.
Source: Lilly