业界动态监管公开信息 · FDA
FDA加速批准pirtobrutinib用于慢性淋巴细胞白血病和小淋巴细胞淋巴瘤
FDA Drugs · 2026-11-10 05:55
摘要
2023年12月1日，美国食品药品监督管理局（FDA）加速批准pirtobrutinib（商品名Jaypirca，礼来公司）用于既往接受过至少两线治疗（包括BTK抑制剂）的成人慢性淋巴细胞白血病或小淋巴细胞淋巴瘤（CLL/SLL）患者。
English
FDA grants accelerated approval to pirtobrutinib for chronic lymphocytic leukemia and small lymphocytic lymphoma
On December 1, 2023, the Food and Drug Administration granted accelerated approval to pirtobrutinib (Jaypirca, Eli Lilly and Company) for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor.