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Sonrotoclax is a more potent, shorter-acting successor to venetoclax. It was approved for mantle cell lymphoma in May 2026 and is in late-stage trials with zanubrutinib for CLL.
Approved in China (late 2025) for relapsed MCL and CLL/SLL after BTK inhibitor, and in the US on 13 May 2026 (accelerated) for relapsed/refractory MCL after ≥2 lines including a BTK inhibitor (BGB-11417-201: ORR 52%, median DOR 15.8 months). In treatment-naive CLL, sonrotoclax + zanubrutinib (BGB-11417-101) produced uMRD in nearly all patients by 96 weeks; phase 3 CELESTIAL-TNCLL (vs venetoclax-obinutuzumab) completes 2026. Shorter half-life allows faster ramp-up and less overlapping myelosuppression.
Ball-and-stick model from PubChem 2D record (no 3D conformer available). PubChem record
Selective BH3-mimetic BCL-2 inhibitor with higher potency and shorter half-life than venetoclax; active against venetoclax-resistant G101V BCL2 in preclinical models. Connects to BCL-2.
1.Sonrotoclax occupies the BH3 groove of BCL-2
Source: www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sonrotoclax-relapsed-or-refractory-mantle-cell-lymphoma. Doses are for orientation; the current label governs.
Sources: NICE search: sonrotoclax. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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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.
Accelerated approval in MCL; priority review, Project Orbis The confirmatory requirement was still open 0.3 years later, when the FDA's table was read. source
| Region | Year | Indication |
|---|---|---|
| China | 2025 | Relapsed/refractory MCL and CLL/SLL after BTK inhibitor |
| US | 2026 | Relapsed/refractory mantle cell lymphoma after ≥2 lines including a BTK inhibitor (accelerated) |
| Adverse event |
|---|
| Neutropenia Most common grade ≥3 event in MCL and CLL studies |
| Tumour lysis syndrome Mitigated by 4-week ramp |
| Diarrhoea, nausea Mostly low grade |
Rates read from the source. Blank cells mean the figure was not sourced, not that it is zero.
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Query for this drug: (TITLE:"Sonrotoclax" OR ABSTRACT:"Sonrotoclax" OR TITLE:"Beqalzi" OR ABSTRACT:"Beqalzi" OR TITLE:"BGB-11417" OR ABSTRACT:"BGB-11417") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Sonrotoclax, not a curated reading list.
Shares A Study to Investigate Efficacy and Safety of BCL2 Inhibitor Sonrotoclax as Monotherapy and in Combination With Zanubrutinib in Adults With Waldenström Macroglobulinemia, A Study to Investigate the Efficacy and Safety of Sonrotoclax Plus Zanubrutinib Compared With Placebo Plus Zanubrutinib in Adults With Relapsed/Refrac, A Study to Investigate the Safety of Novel Dose Ramp-up Schedule(s) When Initiating Sonrotoclax in Participants Treated for Blood Cancers., A Study to Investigate Safety and Effectiveness of Tacabrutideg (BGB-16673) in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies.
Shares MRD-guided treatment duration in CLL, BTK inhibitor + venetoclax, fixed duration, Chronic lymphocytic leukaemia, first treatment, BCL-2.
Shares Tumour lysis syndrome (TLS), BCL-2 inhibitors, Chronic lymphocytic leukaemia, first treatment, BCL-2.
Shares BTK inhibitor + venetoclax, fixed duration, Chronic lymphocytic leukaemia, first treatment, BCL-2, Venetoclax.
Shares BH3 profiling (functional apoptosis testing), Intrinsic apoptosis (BCL-2 family), BCL-2, Venetoclax.
Shares BTK inhibitor + venetoclax, fixed duration, Chronic lymphocytic leukaemia, first treatment, BCL-2, Venetoclax.
Shares BTK degraders to pre-empt resistance in frontline CLL, Relapsed or refractory chronic lymphocytic leukaemia, Chronic lymphocytic leukaemia, first treatment, BeOne Medicines (formerly BeiGene).
Shares Tumour lysis syndrome (TLS), Intrinsic apoptosis (BCL-2 family), BCL-2 inhibitors, BCL-2.