Also known as Jaypirca.
FDA clears pirtobrutinib for newly diagnosed CLL/SLL patients without 17p deletion after BRUIN CLL-313 showed a large PFS benefit versus bendamustine–rituximab.
CHMP issued a positive opinion for pirtobrutinib for adults with CLL across all lines of therapy; application now referred to the European Commission for final decision.
Phase 3 BRUIN CLL-322 found adding pirtobrutinib to a two‑year venetoclax+rituximab regimen reduced progression or death by 45% versus venetoclax+rituximab alone.
