BeOne Medicines Wins Conditional FDA Nod For Cancer Drug In Rare Blood Cancer

benzinga_article
2026.05.14 18:15
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The FDA has granted accelerated approval to BeOne Medicines' BEQALZI (sonrotoclax) for adults with relapsed mantle cell lymphoma after prior BTK inhibitor therapy. This approval provides a new treatment option for patients with limited therapies. The drug showed a 52% overall response rate in clinical trials. The approval is contingent on further confirmation of clinical benefit in ongoing trials. Beqalzi is also under review in Europe and has been approved in China for similar conditions. The drug is expected to launch in the second half of 2026.