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New Pfizer Drug Offers Hope for Advanced Breast Cancer
2 May
Summary
- Veppanu pill approved for advanced ER+, HER2- breast cancer.
- Drug targets patients with specific ESR1 mutation.
- Trial showed longer survival without worsening disease.
The U.S. Food and Drug Administration has granted approval for Veppanu, a new oral medication developed by Pfizer and Arvinas. This drug is indicated for adult patients diagnosed with advanced estrogen receptor-positive, HER2-negative breast cancer that has metastasized or is inoperable.
Eligibility for Veppanu requires patients to have a specific ESR1 genetic mutation and have experienced disease progression following at least one prior hormone therapy. The FDA's decision was informed by a late-stage clinical trial involving 624 participants. Results demonstrated that Veppanu improved patient survival durations without disease progression when contrasted with the established hormone therapy, fulvestrant.
Veppanu's efficacy appears competitive, with notable benefits including higher rates of tumor shrinkage compared to injectable treatments. However, the drug's label includes cautions regarding potential effects on heart rhythm and risks to unborn babies. The companies anticipate announcing a commercialization deal and pricing details in the coming weeks. A companion blood test, Guardant360 CDx, has also been approved to identify eligible patients.
