medcelerator · clinician one-pager
New Pill for Mantle Cell Lymphoma After Prior Treatment
Beqalzi (sonrotoclax) — oral BCL-2 inhibitor for R/R mantle cell lymphoma after ≥2 lines including a BTK inhibitor
FDA Approved · United States, China · September 7, 2026
Condition: Mantle Cell Lymphoma
Who this is for
This is for adults with relapsed or refractory mantle cell lymphoma who have already had at least two systemic treatments, including a BTK inhibitor, and who may be candidates for a labelled US oral BCL-2 tablet with a structured dose ramp-up. It explains the FDA accelerated label, tumor-lysis and infection watchpoints, the BGB-11417-201 numbers behind the approval, the recruiting confirmatory CELESTIAL-RRMCL trial, and how to talk with a lymphoma clinician — without treating a completed pivotal cohort, a China pack, or a DIY import as the care plan. Confirmatory progression-free survival work is still required; authorized is not funded.
Next clinical step
The US Food and Drug Administration (FDA) has approved this medicine. In the United States, ask your doctor or a specialist whether it suits you. They can write a prescription. Insurance or public drug plan coverage is not guaranteed. In China, authorisation is not confirmed; see Possible routes below if any are listed.
Ways to access this treatment
United States · Prescription
US prescription (FDA-labelled)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220711Orig1s000lbl.pdf
United States, China · Recruiting clinical trial
A Study to Investigate the Efficacy and Safety of Sonrotoclax Plus Zanubrutinib Compared With Placebo Plus Zanubrutinib in Adults With Relapsed/Refractory Mantle Cell Lymphoma (CELESTIAL-RRMCL)
Combination or different setting. Tests sonrotoclax combined with zanubrutinib (phase 3).
https://clinicaltrials.gov/study/NCT06742996
United States · Recruiting clinical trial
Sonrotoclax, Rituximab, and Zanubrutinib in Treating Participants With Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, and Mantle Cell Lymphoma
Combination or different setting. Tests sonrotoclax with rituximab and zanubrutinib (phase 2).
https://clinicaltrials.gov/study/NCT06839053
United States · Recruiting clinical trial
BRAZAN: A Randomized Phase 2 Study of Bendamustine, Rituximab, Cytarabine (AraC) Induction With Zanubrutinib (BRAZAN) Followed by Zanubrutinib/Rituximab +/- Sonrotoclax Maintenance in Treatment-Naïve Mantle Cell Lymphoma
Combination or different setting. Tests sonrotoclax with zanubrutinib after chemo-immunotherapy induction, first line (phase 2).
https://clinicaltrials.gov/study/NCT06854003
Search all trials on ClinicalTrials.gov: https://clinicaltrials.gov/search?cond=mantle%20cell%20lymphoma&intr=sonrotoclax&aggFilters=status:rec
Possible routes (not confirmed)
United States · Not yet recruiting clinical trial · Applicability unknown
A Study of Zanubrutinib, Obinutuzumab, and Sonrotoclax in People With Mantle Cell Lymphoma
Trial not yet recruiting (ClinicalTrials.gov status: not yet taking patients).
https://clinicaltrials.gov/study/NCT07799220
General resources for further research
ClinicalTrials.gov
US National Library of Medicine registry of clinical studies. Search by condition, drug, NCT number, and location. A listing is not enrolment, eligibility, or funding. Talk with the trial contact and a clinician before assuming a slot exists.
https://clinicaltrials.gov/
AI-produced discussion aid; not prescribing instructions. Approval does not establish coverage. Full article: https://medcelerator.com/articles/beqalzi-sonrotoclax