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FDA grants accelerated approval to sonrotoclax for R/R MCL
On May 13, 2026, the U.S. Food and Drug Administration (FDA) granted accelerated approval to sonrotoclax, a B-cell lymphoma 2 (BCL2) inhibitor, for the treatment of patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL) following ≥2 lines of systemic therapy, including a Bruton’s tyrosine kinase inhibitor (BTKi).1
Accelerated approval was supported by results from the phase I/II BGB-11417-201 (NCT05471843) study.1 The overall response rate was 52% (95% confidence interval [CI], 42–62), with 16% (95% CI, 9.1–24.0) of patients demonstrating a complete response.1,2 The median time to response was 1.9 months and the median duration of response was 15.8 months.1,2 Sonrotoclax was generally well tolerated, with Grade ≥3 treatment-related adverse events occurring in 36.5% of patients.1,2
Continued approval is reliant upon confirmation of efficacy and safety in the phase III CELESTIAL-RRMCL (NCT06742996) study.1
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In your experience, what is the average vein-to-vein time when treating patients with DLBCL with a reimbursed CAR T-cell therapy (from apheresis to infusion)?
