FDA grants ‘Fast Track’ for Nurix’s for NX-5948 to treat r/r CLL/SLL

Nurix Therapeutics announced that the U.S. Food and Drug Administration FDA has granted Fast Track designation for NX-5948, a highly selective degrader of Bruton’s tyrosine kinase BTK , for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma or r/r CLL/SLL, after at least two lines of therapy, including a BTK inhibito,r BTKi , and a B-cell lymphoma 2, BCL2, inhibitor. “Fast Track designation for NX-5948 is an important recognition of the unmet patient need in CLL, particularly in the growing number of patients whose cancer has progressed following BTK and BCL2 inhibitor therapy,” said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. “This designation follows encouraging safety and efficacy data from our ongoing Phase 1 clinical trial, demonstrating early promise of clinical benefit with potential for durable outcomes. The receipt of Fast Track designation is especially timely given our plans to accelerate enrollment in the Phase 1 trial of NX-5948 with the goal of enabling a pivotal study for NX-5948 as rapidly as possible.” The FDA’s Fast Track designation is intended to facilitate and expedite the development and review of drug candidates to treat serious conditions and fulfill an unmet medical need. To qualify, available clinical and non-clinical data need to demonstrate a therapeutic candidate’s potential to address an unmet medical need. A therapeutic candidate that receives Fast Track designation may be eligible for more frequent interactions with the FDA to discuss the candidate’s development plan and, if relevant criteria are met, eligibility for Accelerated Approval and Priority Review.