辉瑞Talzenna联合Xtandi获FDA扩展批准用于HRR突变mHSPC，但系预期内落地且已被处理

Pfizer Inc. (PFE) announced that the U.S. Food and Drug Administration (FDA) has expanded approval of TALZENNA in combination with XTANDI for the treatment of men with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer with homologous recombination repair (HRR) gene mutations, including both BRCA and non-BRCA mutations.
mAPMN/S is also known as metastatic hormone-sensitive prostate cancer (mHSPC).The approval is based on pivotal Phase 3 TALAPRO-3 data, which showed an estimated 52% reduction in the risk of radiographic progression or death.
Talzenna (talazoparib) is an oral poly ADP-ribose polymerase (PARP) inhibitor, and Xtandi (enzalutamide) is an androgen receptor pathway inhibitor (ARPI).
TALZENNA plus XTANDI was first approved in the U.S. in 2023 for men with metastatic androgen pathway modulation resistant (mAPMR) PC with HRR gene mutations, also known as HRRm metastatic castration-resistant prostate cancer (mCRPC).
Trial Details
TALAPRO-3 (NCT04821622) is a randomized, double-blind, placebo-controlled Phase 3 study that enrolled 599 patients with metastatic androgen pathway modulation-naïve or -sensitive prostate cancer (mAPMN/S PC) who had received up to three months of androgen deprivation therapy, with or without an approved androgen receptor pathway inhibitor.
Patients were randomised to receive TALZENNA (talazoparib) 0.5 mg once daily plus XTANDI (enzalutamide) 160 mg once daily, or placebo plus XTANDI 160 mg once daily.
The primary endpoint was investigator-assessed radiographic progression-free survival (rPFS), defined as the time from randomisation to radiographic disease progression or death from any cause, whichever occurred first.
Key Findings
According to the company, key findings of the phase 3 TALAPRO-3 study include,TALZENNA plus XTANDI reduced the risk of radiographic progression or death by 52% compared with placebo plus XTANDI in patients with mAPMN/S PC with HRR gene mutations, and an estimated 77% of patients remained progression-free at three years.
This approval makes TALZENNA, an oral poly ADP-ribose polymerase (PARP inhibitor, plus XTANDI, an androgen receptor pathway inhibitor (ARPI), available in an earlier line, providing an opportunity to delay disease progression at a critical stage when more patients may experience greater benefit.
The safety profile of TALZENNA (talazoparib) plus XTANDI (enzalutamide) was consistent with the known safety profiles of the individual agents, with no new safety signals identified.
The most common treatment-emergent adverse events (TEAEs) in the combination arm were anaemia, fatigue, decreased neutrophil count, and asthenia.
The most frequently reported grade 3 or higher TEAE was anemia, occurring in 51% of patients receiving TALZENNA plus XTANDI, compared with 3% of patients in the control group. Anaemia led to the discontinuation of TALZENNA in 5% of patients. Overall, TEAEs were generally manageable through dose modifications and supportive care when needed, the company said.
Stock Performance
PFE has traded between $23.62 and $30.44 over the last year. The stock closed Monday's trade at $29.79, down 0.80%.
For more such biotech stock news, visit www.rttnews.com.
For comments and feedback contact: editorial@rttnews.com
Business News
October 16, 2026 16:06 ET Monthly consumer price inflation data and retail sales figures were the main news from the U.S. economy this week. In Europe, monthly GDP figures from the U.K. gained attention. External trade data from China was in focus in Asia. Elsewhere, the International Monetary Fund released its latest projections for the global economy.