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# Nurix Therapeutics Gets Fast Track Status
- URL: https://www.fdaweb.com/nurix-therapeutics-gets-fast-track-status/
- Published: 2024-01-17T12:00:00.000Z
- Updated: 2026-09-14T14:20:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156155

FDA has granted Nurix Therapeutics a fast track designation for NX-5948, a highly selective degrader of Bruton’s tyrosine kinase (BTK) for treating adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma after at least two lines of therapy, including a BTK inhibitor and a B-cell lymphoma 2 inhibitor.

The designation follows recent company-reported clinical data from a dose escalation Phase 1a/1b trial that found six of the seven patients in the CLL population that received doses ranging from 50 to 200 mg demonstrated clinical benefit with three partial responses.

Additionally, the company says NX-5948 was well-tolerated across all doses tested with no dose limiting toxicities or treatment-related serious adverse events.