Lilly receives positive CHMP opinion for Jaypirca in CLL

• Lilly (NYSE:LLY) received a positive CHMP opinion recommending approval of Jaypirca (pirtobrutinib) for adults with chronic lymphocytic leukemia across all lines of therapy.
• The recommendation covers patients regardless of prior BTK inhibitor treatment, based on two Phase 3 BRUIN trials.
• If approved by the European Commission, Jaypirca would offer a new treatment option for CLL patients in the EU.

Lilly (NYSE:LLY) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending marketing authorization for Jaypirca (pirtobrutinib) in adults with chronic lymphocytic leukemia (CLL).

The opinion covers use across all lines of therapy, regardless of prior BTK inhibitor exposure.

The recommendation is based on results from the Phase 3 BRUIN CLL-313 and BRUIN CLL-314 trials.

If approved by the European Commission, Jaypirca would become a new treatment option for CLL patients in the European Union.

The European Commission is expected to issue a final decision in the coming one to two months.

Lilly has also submitted the BRUIN CLL data to the U.S. FDA, with a decision anticipated in the second half of 2026.