Treats relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of…. NDA 220711, held by Beone Medicines USA. Sonrotoclax.
As of Nov 14, 2026, NDA 220711 (Beqalzi), held by Beone Medicines USA, was first approved by FDA on May 13, 2026, with 0 approved supplements and 0 published complete response letters.
BEQALZI is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton's tyrosine kinase (BTK) inhibitor. This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 13, 2026 | Original applicationNew molecular entity · Priority review | Approved |
| Beqalzi1MG · tablet;oral | Sonrotoclax | RxReference drug |
| Beqalzi5MG · tablet;oral | Sonrotoclax | RxReference drug |
| Beqalzi20MG · tablet;oral | Sonrotoclax | RxReference drug |
| Beqalzi80MG · tablet;oral | Sonrotoclax | RxReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
