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Nurix Therapeutics Receives U.S. FDA Fast Track Designation for NX-5948 for the Treatment of Relapsed or Refractory CLL and SLL
Fast track designation follows positive Phase 1 data presented at the American Society of Hematology that supports strategy to broadly develop NX-5948 in CLL
About this update from Nurix Therapeutics, Inc.
[{"type":"text","content":"Fast track designation follows positive Phase 1 data presented at the American Society of Hematology that supports strategy to broadly develop NX-5948 in CLL and other non-Hodgkin lymphoma indications\nSAN FRANCISCO, Jan. 16, 2024 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with cancer and inflammatory diseases, today 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 (r/r CLL/SLL) after at least two lines of therapy, including a BTK inhibitor (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. Nurix recently reported positive clinical data from the dose escalation stage of its Phase 1a/1b clinical trial evaluating daily oral dosing of BTK degrader NX-5948 in patients with r/r B-cell malignancies at the Ameri...