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May 02, 2026
FDA has accepted the NDA for vepdegestrant (ARV-471), an oral PROTAC ER degrader from Arvinas and Pfizer, for ESR1-mutated ER+/HER2- advanced breast cancer. A PDUFA date of June 5, 2026 has been set. The submission is based on positive Phase 3 VERITAC-2 data.
Feb 20, 2026
The FDA has accepted Roche's new drug application for giredestrant in combination with everolimus for ER-positive, HER2-negative, ESR1-mutated breast cancer, with a decision expected by December 18, 2026.
Apr 19, 2025
CDK4/6 inhibitors have transformed HR+/HER2− breast cancer treatment, while emerging resistance mechanisms are driving development of selective CDK2 inhibitors and dual CDK2/4 strategies to address treatment failure.
