Nurix Therapeutics, Inc. (Nasdaq: NRIX) has disclosed that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for NX-5948, a selective degrader of Bruton’s tyrosine kinase (BTK), designed for the treatment of adult patients dealing with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (r/r CLL/SLL) after undergoing at least two lines of therapy, including a BTK inhibitor (BTKi) and a B-cell lymphoma 2 (BCL2) inhibitor.
According to Arthur T. Sands, M.D., Ph.D., President, and CEO of Nurix, the Fast Track designation for NX-5948 is a significant acknowledgment of the unmet needs of patients with CLL, especially those facing disease progression after BTK and BCL2 inhibitor therapy. Dr. Sands highlighted the encouraging safety and efficacy data emerging from the ongoing Phase 1 trial, prompting plans to expedite enrollment and facilitate a pivotal study for NX-5948 as quickly as possible.
The Fast Track designation by the FDA is designed to streamline the development and review process for drug candidates targeting serious conditions with unmet medical needs. Candidates receiving this designation may benefit from increased interactions with the FDA and potential eligibility for Accelerated Approval and Priority Review, subject to specific criteria.
Nurix recently presented positive clinical data for NX-5948 in the Phase 1a/1b trial for r/r B-cell malignancies. Notably, six out of seven CLL patients exhibited clinical benefit, with ongoing partial responses. NX-5948 demonstrated favorable tolerability, and there were no significant adverse events. Ongoing enrollment for the study continues, with expectations for data on higher dose levels and longer treatment durations in 2024.
NX-5948 is an investigational, orally bioavailable BTK degrader currently undergoing Phase 1 evaluation. It has demonstrated potency against resistant tumor cell lines, making it pertinent for heavily pretreated CLL/SLL patient populations. Further details about the clinical trial can be found on clinicaltrials.gov (NCT05131022).
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