Also known as Imbruvica.
FDA clears pirtobrutinib for newly diagnosed CLL/SLL patients without 17p deletion after BRUIN CLL-313 showed a large PFS benefit versus bendamustine–rituximab.
Quarterly sales topped $25.3B; adjusted net earnings and EPS rose, free cash flow improved, and full-year revenue guidance was raised above $100B for the first time.
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.