News/Regulation/Jun 29, 2026

EU regulator backs Jaypirca for CLL across all treatment lines

The EU's medicines committee gave a positive opinion for Jaypirca (pirtobrutinib) in adults with chronic lymphocytic leukaemia across all lines of therapy, including patients who have not had a BTK inhibitor. The opinion is based on the Phase 3 BRUIN CLL-313 and CLL-314 trials. The European Commission is expected to decide within one to two months, which would make it a final EU approval.

  • Covers all treatment lines, with or without prior BTK inhibitor therapy
  • Based on BRUIN CLL-313 and CLL-314 Phase 3 trials
  • European Commission decision expected within one to two months
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Source
Pharmaceutical Technology
Jun 29, 2026
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