Arvinas, Inc. (ARVN), together with Pfizer Inc. (PFE), announced that the U.S. FDA has approved VEPPANU for adult patients with estrogen receptor-positive (ER+)/HER2-negative, ESR1-mutated advanced or metastatic breast cancer, following disease progression after at least one line of endocrine therapy.
VEPPANU is the first FDA-approved PROteolysis TArgeting Chimera (PROTAC), a novel class of protein degrader therapies. This milestone represents Arvinas' first approved medicine and marks a significant advancement in targeted protein degradation technology.
The approval was supported by results from the pivotal Phase 3 VERITAC-2 trial, which compared VEPPANU to fulvestrant in patients with ESR1 mutations. VEPPANU reduced the risk of disease progression or death by 43%, with median progression-free survival of 5 months versus 2.1 months with fulvestrant. Safety data showed most adverse events were low-grade, with common effects including fatigue, musculoskeletal pain, and laboratory abnormalities.
Breast cancer remains the most common cancer among women worldwide, and resistance to endocrine therapy due to ESR1 mutations is a major clinical challenge. VEPPANU provides a new oral treatment option, offering improved outcomes compared to current standards.
This approval underscores the potential of Arvinas' PROTAC platform and strengthens its pipeline across oncology and other therapeutic areas. Arvinas and Pfizer plan to select a third-party partner to support commercialization of VEPPANU.
ARVN has traded between $5.90 and $14.51 over the past year. The stock closed Friday's trading at $10.51, up 6.16%. During after-hours trading, the stock traded at $10.54, up 0.28%.
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