SAN FRANCISCO, Dec. 19, 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 Waldenstrom’s macroglobulinemia (WM) after at least two lines of therapy, including a BTK inhibitor.“Fast Track designation for NX-5948 is an important recognition of the unmet patient need in Waldenstrom’s macroglobulinemia, particularly in the growing number of patients whose cancer has progressed following BTK inhibitor therapy,” said Arthur T.

Nurix Therapeutics, Inc.（纳斯达克股票代码：NRIX）今天宣布，美国食品和药物管理局（FDA）已批准NX-5948（一种高选择性降解布鲁顿酪氨酸激酶（BTK）的药物）进入快速通道，用于治疗成人癌症和炎症性疾病患者。NX-5948是一种布鲁顿酪氨酸激酶（BTK）高选择性降解剂，用于治疗经过至少两线治疗（包括BTK抑制剂）后复发或难治的瓦尔登斯特罗姆巨球蛋白血症（WM）成人患者。 NX-5948被指定为 “快速通道 ”药物是对瓦尔登斯特罗姆巨球蛋白血症患者未得到满足的需求的重要认可，尤其是越来越多的患者在接受BTK抑制剂治疗后癌症出现进展。

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. We continue to enroll Waldenstrom’s macroglobulinemia patients in the ongoing Phase 1b expansion cohort and anticipate sharing additional clinical data in 2025.”In addition to the Fast Track designation announced today for Waldenstrom’s macroglobulinemia, NX-5948 previously received Fast Track designation in January 2024 for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) after at least two lines of therapy, including a BTK inhibitor and a B-cell lymphoma 2 (BCL2) inhibitor.

Nurix总裁兼首席执行官桑兹（Sands，M.D.，Ph.D.）“这一任命是基于我们正在进行的第一阶段临床试验的令人鼓舞的安全性和有效性数据，证明了临床获益的早期前景，并有可能取得持久的结果。我们继续在正在进行的1b期扩展队列中招募Waldenstrom巨球蛋白血症患者，并预计在2025年分享更多的临床数据。”除了今天宣布的Waldenstrom巨球蛋白血症快速通道指定外，NX-5948先前于2024年1月接受了快速通道指定，用于治疗至少两行复发或难治性慢性淋巴细胞白血病或小淋巴细胞淋巴瘤（CLL/SLL）的成年患者。治疗，包括BTK抑制剂和B细胞淋巴瘤2（BCL2）抑制剂。

In November 2024, the European Medicines Agency (EMA) granted NX-5948 PRIME designation for the treatment of adult patients with relapsed or refract.

2024年11月，欧洲药品管理局（EMA）授予NX-5948主要名称，用于治疗复发或折射的成年患者。