Life Sciences Daily Summary: What Happened on October 27, 2026

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.12 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