美国食品药品监督管理局（FDA）顾问委员会近日对阿斯利康制药旗下抗癌药物Truqap（capivasertib）给予积极推荐，支持其用于治疗PTEN缺陷型转移性激素敏感性前列腺癌（mHSPC）患者。
这一重要建议标志着Truqap在拓展前列腺癌适应症方面取得关键进展。PTEN基因缺失是前列腺癌中常见的分子变异，与疾病进展和治疗耐药性密切相关。临床数据显示，针对该生物标志物的人群，Truqap联合标准疗法展现出显著疗效优势。
委员会基于三期临床试验CAPItello-281的积极结果作出推荐。该研究证实，在PTEN缺失的转移性激素敏感性前列腺癌患者中，Truqap治疗方案能显著延长影像学无进展生存期，为这类特定人群提供了新的精准治疗选择。
FDA通常遵循顾问委员会的建议，但最终决定仍待官方审评。若获批，Truqap将成为首个针对PTEN缺陷型mHSPC的靶向疗法，填补当前治疗格局中的重要空白。
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.