智通财经APP讯,德琪医药-B(06996)发布公告,印度尼西亚食品药品监督管理局(BPOM)已批准希维奥®(塞利尼索片)用于三项适应症的新药上市申请(NDA):(1)与硼替佐米和地塞米松联用,用于治疗既往接受过至少一种先前治疗的多发性骨髓瘤(MM)的成年患者;(2)联合地塞米松用于治疗既往接受过至少四次既往治疗且对至少两种蛋白酶体抑制剂(PI)、至少两种免疫调节剂(IMiD)、一种抗CD38单克隆抗体难治的复发或难治性多发性骨髓瘤(rrMM)的成年患者;及(3)作为单药用于治疗复发或难治性弥漫性大B细胞淋巴瘤(rrDLBCL)成年患者,除另有说明外,其包含接受过至少两线系统性治疗且不符合造血干细胞移植的由滤泡性淋巴瘤引起的弥漫性大B细胞淋巴瘤。
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.