--- title: 'Life Sciences Daily Summary: What Happened on October 27, 2026' headline: FDA extends Pfizer’s Talzenna-Xtandi combination to earlier prostate cancer description: The decision covers hormone-sensitive disease with HRR mutations. An EU committee also recommended olezarsen for severe hypertriglyceridemia. url: https://thebench.bio/news/summaries/2026-10-27 topic: all date: '2026-10-27' covers: - '2026-10-27' date_published: '2026-10-27T12:05:21Z' date_modified: '2026-10-27T12:05:21Z' tags: - Regulatory sources: 3 publisher: TheBench.Bio --- # Life Sciences Daily Summary: What Happened on October 27, 2026 **FDA extends Pfizer’s Talzenna-Xtandi combination to earlier prostate cancer** The decision covers hormone-sensitive disease with HRR mutations. An EU committee also recommended olezarsen for severe hypertriglyceridemia. ## Today in brief Pfizer’s Talzenna-Xtandi combination is now approved for some adults with metastatic hormone-sensitive prostate cancer and HRR mutations. [1] [2] In TALAPRO-3, it lowered the risk of radiographic progression or death by 52% versus Xtandi alone. [2] An EU committee backed olezarsen for adults with severe hypertriglyceridemia and fasting triglycerides of at least 880 mg/dL. [3] The European Commission was expected to decide on authorization in the fourth quarter of 2026. [3] ## FDA expands Pfizer’s prostate cancer combination to hormone-sensitive disease The FDA expanded Talzenna, or talazoparib, with Xtandi, or enzalutamide, to adults with metastatic hormone-sensitive prostate cancer whose tumors have homologous recombination repair (HRR) mutations. [1] [2] The indication covers disease that has not been treated with androgen-pathway drugs or remains sensitive to them, and requires confirmation of an HRR mutation with an FDA-authorized test. [2] In the Phase 3 TALAPRO-3 trial, 599 patients received talazoparib or placebo, each with enzalutamide. [2] The combination lowered the risk of radiographic progression or death by 52%, with benefit reported in patients with both BRCA and non-BRCA mutations. [2] Median time without radiographic progression had not been reached with the combination, compared with 45.8 months with placebo and enzalutamide. [2] Overall survival results were still immature. [2] Pfizer reported no new safety signals, and severe anemia was the most common grade 3 or higher adverse event. [2] The prescribing information requires monthly blood-count monitoring and warns of myelodysplastic syndrome, acute myeloid leukemia, and fetal harm. [2] ## EU committee recommends olezarsen for severe hypertriglyceridemia The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended olezarsen with diet and other lipid-lowering treatments for adults with severe hypertriglyceridemia and fasting triglycerides of at least 880 mg/dL. [3] The recommendation was based on the Phase 3 CORE and CORE2 studies, which enrolled 1,063 adults with triglyceride levels of at least 500 mg/dL. [3] At six months, olezarsen lowered fasting triglycerides by up to 72% versus placebo, with the reduction sustained through 12 months. [3] A pooled analysis found an 85% lower rate of acute pancreatitis events over 12 months with olezarsen than with placebo. [3] Severe hypertriglyceridemia raises the risk of acute pancreatitis, which can cause severe illness and lasting organ damage. [3] The European Commission was expected to decide on authorization in the fourth quarter of 2026. [3] ## The day in numbers - **52%**: Lower risk of radiographic progression or death with Talzenna and Xtandi versus Xtandi alone in TALAPRO-3. [2] - **880 mg/dL**: Fasting triglyceride threshold for the EU indication recommended for olezarsen. [3] - **85%**: Lower acute pancreatitis event rate with olezarsen versus placebo in a pooled 12-month analysis. [3] ## Sources 1. [Pfizer’s prostate cancer combo moves to earlier line on expanded US approval  ](), Pharmaceutical Technology, 2026-10-27 2. [FDA Extends Talzenna-Xtandi to Hormone-Sensitive Prostate Cancer](), Pharmaceutical Executive, 2026-10-26 3. [Sobi’s olezarsen recommended for EU approval in severe hypertriglyceridaemia](), Pharmafile, 2026-10-27 --- TheBench.Bio wrote this from the reporting cited above, with a language model drafting and editing. [1]: [2]: [3]: