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Arvinas Announces FDA Approval of VEPPANU (vepdegestrant) for the Treatment of ESR1m, ER+/HER2- Advanced Breast Cancer
– VEPPANU™ is the first-and-only FDA-approved PROTAC, a type of heterobifunctional protein degrader – – Approval received in advance of FDA-assigned PDUFA
About this update from Arvinas, Inc.
[{"type":"text","content":"– VEPPANU™ is the first-and-only FDA-approved PROTAC, a type of heterobifunctional protein degrader – – Approval received in advance of FDA-assigned PDUFA date of June 5, 2026; Arvinas and Pfizer remain on track to announce selection of a third party – – VEPPANU offers a new therapeutic option in ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer, where treatment resistance remains a major clinical challenge – NEW HAVEN, Conn., May 01, 2026 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), today with its partner Pfizer Inc. (NYSE: PFE), announced that the U.S. Food and Drug Administration (FDA) has granted approval for VEPPANU (vepdegestrant) for the treatment of adults with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-), estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy. This approval marks the first time the FDA has approved a PROteolysis TArgeting Chimera (PROTAC), a type of heterobifunctional protein degrader therapy. “Today’s FDA approval is a transformative moment for Arvinas as we achieve our first approved medicine and the first-ever approved PROTAC therapy based on the technology we’ve pioneered since 2013,” said Randy Teel, Ph.D., President and Chief Executive Officer at Arvinas. “This milestone demonstrates that targeted protein degradation can translate into meaningful clinical impact. It also strengthens our confidence in the breadth and versatility of our exciting clinical pipeline across oncology, neurodegenerative, and neuromuscular diseases. We are especially encouraged by receiving FDA approval ahead of the June 5 PDUFA date and together with Pfizer, we are on track to announce selection of a third party to bring this new treatment option to patients as soon as possible.” “For patients living with ESR1 mutant, ER+/HER2 advanced breast cancer, there have been minimal second-line treatment options once standard therapies are no longer effective,” said Erika Hamilton, M.D., Chief Development Officer, Late Phase, and Director, Breast Cancer Research, Sarah Cannon Research Institute, as well as a principal investigator of the VERITAC-2 trial. “The introduction of a new, targeted treatment is an encouraging development for this co...