Posted by Michael Wonder on 13 May 2026
FDA grants accelerated approval to sonrotoclax for relapsed or refractory mantle cell lymphoma
13 May 2026 - Today, the FDA granted accelerated approval to sonrotoclax (Beqalzi, BeOne Medicines), a BCL-2 inhibitor, for adults with relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.
Efficacy was evaluated in BGB-11417-201, a single-arm, multi-centre trial in 103 adults with relapsed or refractory mantle cell lymphoma who previously received anti-CD20-based therapy and a BTK inhibitor.
