Study summary

A next-generation BCL-2 pill won accelerated approval for heavily treated mantle cell lymphoma

Sonrotoclax approval · Phase 1/2 · FDA accelerated approval May 2026

What was tested

Sonrotoclax, a more potent and selective successor to venetoclax, as a single drug for relapsed or refractory mantle cell lymphoma after at least two treatments including a BTK inhibitor.

What they found

• Approved based on response rates in people whose disease had progressed after a BTK inhibitor.
• A phase 3 trial (CELESTIAL-RRMCL) now tests sonrotoclax plus zanubrutinib earlier.

What it means

Adds a new option for one of the hardest situations in this disease: relapse after a BTK inhibitor.