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February 7, 2024

FDA grants Fast Track designation for Arvinas’ new breast cancer drug

Contributed New Haven-based Arvinas Inc., above, is collaborating with Pfizer Inc. on a new breast cancer drug.

The U.S. Food and Drug Administration has granted Fast Track designation to a new breast cancer treatment from Arvinas Inc. and Pfizer Inc., the companies announced Tuesday.

The designation is to investigate the drug vepdegestrant (ARV-471), which is intended to treat adults with a specific form of breast cancer, the companies said. The form of cancer is called the estrogen receptor (ER) positive/human growth epidermal growth factor 2 (HER2) negative, or ER+/HER2-. 

Vepdegestrant is being jointly developed by Arvinas and Pfizer.

Fast Track is a process designed to facilitate development and expedite the review of drugs to treat serious conditions and fill an unmet medical need, the FDA said. The intent is to get important new drugs to patients earlier. 

Vepdegestrant is a monotherapy — using a single drug to treat a disease — and is being studied in a clinical trial evaluating both it and another drug, fulvestrant, in patients with locally advanced or metastatic breast cancer who have been previously treated with an endocrine-based therapy.

Dr. Roger Dansey, Pfizer’s chief development officer, oncology, said receiving Fast Track designation reinforces the potential of vepdegestrant to provide “an important new therapeutic option for people with ER+/HER2- breast cancer whose disease has progressed.”

In preclinical studies, vepdegestrant significantly shrank tumors and increased anti-tumor activity when compared to fulvestrant, the companies said. 

In July 2021, New Haven-based Arvinas announced a collaboration with New York-based Pfizer to co-develop and co-commercialize vepdegestrant. Both companies will equally share worldwide development costs, commercialization expenses, and profits. 

Clinical trials will continue to monitor and evaluate the safety and anti-tumor activity of vepdegestrant.

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