百济神州的 BRUKINSA (zanubrutinib) 获得 FDA 加速批准,用于与 obinutuzumab 联合治疗复发或难治性滤泡性淋巴瘤。 BeiGene's BRUKINSA (zanubrutinib) receives accelerated FDA approval for treating relapsed or refractory follicular lymphoma in combination with obinutuzumab.
百济神州的 BRUKINSA (zanubrutinib) 获得 FDA 加速批准,用于在经过两线或以上全身治疗后联合 obinutuzumab 治疗复发或难治性 (R/R) 滤泡性淋巴瘤 (FL) 成人患者。 BeiGene's BRUKINSA (zanubrutinib) receives accelerated FDA approval for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) in combination with obinutuzumab, after two or more lines of systemic therapy. 这标志着 BRUKINSA 在美国的第五个 B 细胞恶性肿瘤适应症。 This marks the fifth indication in B-cell malignancies in the U.S. for BRUKINSA. 这是第一个也是唯一一个被批准用于对初始治疗没有反应或已经复发的滤泡性淋巴瘤患者的 BTK 抑制剂治疗。 It is the first and only BTK inhibitor treatment approved for follicular lymphoma patients who have not responded to initial therapies or have experienced relapse.