Pfizer’s Talzenna, Xtandi Expand Into Prostate Cancer With Another FDA Approval

Pfizer (PFE) reported positive Phase 3 trial results for ELREXFIO in relapsed or refractory multiple myeloma, meeting its primary endpoint of progression-free survival. The study showed significant risk reduction compared to existing treatments. Pfizer also announced FDA approval for Talzenna in combination with Xtandi for metastatic hormone-sensitive prostate cancer with HRR gene mutations. PFE stock is down slightly in pre-market trading.

Pfizer's ELREXFIO met primary endpoint in Phase 3 trial for multiple myeloma, showing 68% 18-month PFS. The study involved 523 patients. No new safety concerns were found. Pfizer plans regulatory submissions and future data presentations. PFE shares were down 0.34% in pre-market trading.

Pfizer reported positive Phase 3 trial results for ELREXFIO in multiple myeloma, showing 68% of patients alive without disease progression at 18 months. The trial compared ELREXFIO to standard regimens, with Pfizer planning global regulatory submissions. ELREXFIO is already approved in the U.S. for certain patients, and Pfizer is exploring earlier treatment uses.

The FDA expanded Pfizer's Talzenna-Xtandi approval for earlier prostate cancer treatment. Based on the TALAPRO-3 study, the combo reduced progression/death risk by 52%. It now treats metastatic hormone-sensitive prostate cancer with HRR gene mutations. Pfizer aims to address unmet needs in this patient population.

Pfizer (PFE) reported that its Phase 3 study of ELREXFIO (elranatamab) met its primary endpoint, showing a significant reduction in disease progression or death in relapsed or refractory multiple myeloma patients. The study involved 523 adults across 26 countries. Pfizer plans to submit the data to global health authorities. ELREXFIO is already approved in over 35 countries for similar indications.

Pfizer reported that its Phase 3 MagnetisMM-32 trial for ELREXFIO met its primary endpoint, showing a 68% progression-free survival rate at 18 months. The company plans regulatory filings, though overall survival data is not yet mature. According to Pfizer, the results support ELREXFIO's potential use in earlier relapsed/refractory multiple myeloma settings.