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.
The liposomal doxorubicin market is projected to grow from $1.32 billion in 2025 to $1.77 billion by 2030, while the broader breast cancer drugs market is expected to reach $54.49 billion by 2036. Growth is driven by increasing cancer incidence, adoption of targeted therapies, and advancements in drug delivery systems including liposomal formulations and antibody-drug conjugates.
The FDA has accepted Roche's new drug application for oral SERD giredestrant in ESR1-mutated, ER-positive advanced breast cancer, with a decision expected by December 18, 2026. The filing is restricted to the ESR1-mutant population despite phase 3 trial benefits in broader patients.
The global biopharmaceutical industry entered 2026 facing one of the largest waves of patent expirations in its history, with $200-300 billion in yearly sales at risk through 2032 as major drugs lose exclusivity.
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.
