智通财经APP获悉，美国食品药品监督管理局(FDA)周二正式批准了由辉瑞(PFE.US)与日本小野制药等公司合作开发的口服抗癌药Braftovi一线联合方案用于结直肠癌治疗。该决定基于辉瑞3期BREAKWATER临床试验数据。FDA允许这款每日一次的药物作为联合疗法的一部分，用于既往未经治疗、携带BRAF V600E突变的转移性结直肠癌患者。
在BREAKWATER研究达到与确认总缓解率相关的双重主要终点之一后，FDA于2024年12月通过加速审批途径批准了Braftovi的同一适应症。关于另一项无进展生存期的双重主要终点，FDA表示，Braftovi联合抗癌药物西妥昔单抗在研究中使新诊断BRAF V600E突变转移性结直肠癌患者的中位无进展生存期达到12.8个月。
Braftovi的活性药物成分encorafenib是一种口服小分子BRAF抑制剂。资料显示，BRAF突变出现在高达15%的转移性结直肠癌患者中，这些患者的预后很差。BRAF V600E突变是最常见的BRAF突变，携带BRAF V600E突变的CRC患者死亡率是野生型BRAF患者的2倍以上。
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.