May. 1 at 11:35 PM
Arvinas shares surged after trading resumed on Friday following the U.S. FDA’s approval of VEPPANU (vepdegestrant), a drug developed in partnership with Pfizer, for patients with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer who have already progressed after at least one line of endocrine therapy.
The approval is a major milestone because VEPPANU becomes the first-ever PROTAC (proteolysis-targeting chimera) therapy authorized by the FDA. This class of drugs works by degrading disease-causing proteins rather than just blocking them, representing a new approach in targeted cancer treatment.
According to Arvinas and Pfizer, the decision also came earlier than expected, being granted ahead of the formal PDUFA action date of June 5, 2026, signaling strong regulatory confidence in the treatment’s safety and efficacy profile.
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