Key Takeaways
The U.S. Food and Drug Administration granted approval to Arvinas Inc. and Pfizer Inc. for their breast cancer therapy, VEPPANU, for patients with a common but difficult-to-treat form of advanced disease. The decision marks the first-ever approval for a new class of drugs known as PROTAC protein degraders.
“Today’s FDA approval is a transformative moment for Arvinas as we achieve our first approved medicine and the first-ever approved PROTAC therapy,” Randy Teel, President and Chief Executive Officer at Arvinas, said in a statement. “This milestone demonstrates that targeted protein degradation can translate into meaningful clinical impact.”
The approval was based on a Phase 3 trial where VEPPANU, also known as vepdegestrant, showed a statistically significant 43 percent reduction in the risk of disease progression or death compared to the standard-of-care drug fulvestrant. Patients taking vepdegestrant had a median progression-free survival of 5 months, more than double the 2.1 months for those on fulvestrant.
The therapy is approved for adults with estrogen receptor-positive (ER+), HER2-negative advanced or metastatic breast cancer that has an ESR1 mutation. Up to half of patients with this type of breast cancer develop ESR1 mutations, which can make tumors resistant to standard endocrine therapies. Shares of Arvinas (ARVN) rose 3.7% in afternoon trading following the news.
VEPPANU’s approval introduces a new therapeutic modality. PROTACs, or PROteolysis TArgeting Chimeras, are designed to harness the body’s own cellular machinery to selectively destroy disease-causing proteins. This approach, pioneered by Arvinas co-founder Craig Crews at Yale University, differs from traditional drugs that only inhibit protein function.
The approval validates Arvinas's platform and could pave the way for other protein degrader therapies in the company's pipeline, which includes candidates for neurodegenerative and neuromuscular diseases. Competitors in the protein degrader space include companies like Kymera Therapeutics and C4 Therapeutics.
Arvinas and Pfizer, which have been jointly developing the drug since July 2021, plan to select a third-party partner to handle the commercial launch and maximize the drug's market potential.
The most common adverse events reported in the VERITAC-2 trial were generally low-grade and included decreased white blood cells, elevated liver enzymes, musculoskeletal pain, and fatigue.
The approval for vepdegestrant validates Arvinas's targeted protein degradation platform, a new frontier in medicine. Investors will now focus on the selection of a commercial partner and the initial sales trajectory to gauge the therapy's market adoption.
This article is for informational purposes only and does not constitute investment advice.
