FDA clears Pfizer, Arvinas’ novel breast cancer therapy despite mixed data

Veppanu, the first PROTAC therapy approved by the FDA, improved progression free survival by 43% versus AstraZeneca’s Faslodex but showed no such significant benefit in the intention-to-treat analysis.

The FDA on Friday greenlit Pfizer and Arvinas’ protein degrader Veppanu for the treatment of certain types of breast cancer as the first-ever PROTAC therapy. Results from the Phase 3 VERITAC-2 study paved the way for Veppanu’s approval, despite mixed topline data in March last year.

Short for proteolysis-targeting chimeras, these drugs actively target and destroy disease-causing molecules. Veppanu, formerly known as vepdegestrant, is specifically indicated for patients with advanced or metastatic ER-positive and HER2-negative breast cancer who also harbor mutations in the ESR1 gene. Only those who have progressed after a prior line of endocrine therapy are eligible for Veppanu.

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