抗癌药物扩大适应症

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FDA专家组质疑数据有效性 辉瑞(PFE.US)前列腺癌药Talzenna扩大适应症遇挫
Zhi Tong Cai Jing· 2025-05-22 07:33
Core Viewpoint - Pfizer's attempt to expand the indication for its prostate cancer drug Talzenna has faced significant setbacks, as an independent expert panel unanimously voted against supporting the application due to insufficient data [1][2]. Group 1: Drug Approval and Clinical Trials - Talzenna is currently approved only for prostate cancer patients with specific genetic mutations, and Pfizer aimed to double the eligible patient population based on clinical trial data suggesting survival benefits for all patients regardless of genetic status [1]. - The FDA and its advisors raised concerns about the validity of Pfizer's supportive research, with some experts doubting the drug's efficacy for patients without genetic mutations and suggesting that positive results might be due to random chance [1][2]. Group 2: Financial Implications - Talzenna is one of the few cancer drugs that Pfizer hopes will become a multi-billion dollar product in the coming years, especially as the company faces a projected annual revenue loss of approximately $15 billion by 2030 due to declining COVID-19 product sales and patent expirations of older drugs [1].