First PROTAC Breast Cancer Treatment Surpasses FDA Threshold Ahead of PDUFA

Arvinas, Inc. (NASDAQ: ARVN) and partner Pfizer have received the FDA’s first-ever approval of a PROTAC protein degrader—VEPPANU—for oral monotherapy in adult patients with ER+/HER2-, ESR1-mutant advanced or metastatic breast cancer. This accelerated approval came ahead of the June 5 PDUFA date.

In the Phase 3 VERITAC-2 trial, VEPPANU demonstrated a more than 40% reduction in the risk of disease progression or death compared with fulvestrant. The two companies plan to jointly select a third partner to maximize the therapy’s commercial potential.

In its Q1 2026 earnings release, Arvinas disclosed a licensing agreement granting Rigel Pharmaceuticals global development, manufacturing and commercialization rights for VEPPANU, alongside governance changes including the appointment of a new CEO. As of March 31, the company reported approximately $615 million in cash and equivalents—roughly KRW 800 billion—enough to fund operations through H2 2028.

According to Arvinas’s website, the approval of VEPPANU coincides with initial data showing that ARV-102, targeting Parkinson’s disease, reduces LRRK2 protein levels in cerebrospinal fluid by over 50%, underscoring the company’s pipeline expansion across neurology and oncology.

Arvinas is also maintaining its global partnership with Pfizer while preparing additional breast cancer indications, combination-therapy studies and data presentations to broaden VEPPANU’s clinical and commercial footprint.

Arvinas is a U.S. biotech leveraging proteolysis-targeting chimera (PROTAC) technology, with multiple clinical-stage candidates—including ARV-766 for prostate cancer—focused on hard-to-treat cancers and neurological disorders. By harnessing the ubiquitin-proteasome system to selectively degrade disease-related proteins, PROTACs are emerging as next-generation targeted therapies and attracting collaboration and acquisition interest from major pharmaceutical companies.