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A new meta-analysis confirms sonrotoclax works in tough-to-treat lymphoma. Pooling data from 145 patients across 4 cohorts, the BCL-2 inhibitor sonrotoclax (Beqalzi) showed consistent response rates in relapsed/refractory mantle cell lymphoma (MCL), with an overall response rate ranging from 37.5% to 70.0% depending on the cohort. The drug received FDA accelerated approval in May 2026 for patients who've had at least 2 prior lines of therapy.
A systematic review and meta-analysis presented at the 2026 Society of Hematologic Oncology (SOHO) Annual Meeting found that sonrotoclax (Beqalzi)-based regimens produced consistent responses in patients with heavily pretreated relapsed/refractory mantle cell lymphoma (MCL). The analysis pooled data from 4 prospective, single-arm cohorts totaling 145 patients, with a pooled odds ratio for overall response rate (ORR) of 3.84 and for complete response (CR) rate of 2.17 — both statistically significant.
Response rates varied by cohort, with the highest ORR seen in patients receiving sonrotoclax combined with zanubrutinib (Brukinsa) at 70.0%, compared to 53.4% in the pivotal monotherapy cohort. The safety profile was manageable, with neutropenia being the most common serious blood-related side effect and clinical tumor lysis syndrome (TLS) occurring in only 1.4% of patients.
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Why it matters: Sonrotoclax's FDA accelerated approval in May 2026 gives oncologists a new tool for MCL patients who've exhausted BTK inhibitor options and may not yet be eligible for CAR T-cell therapy — filling a critical gap in a notoriously hard-to-treat disease.