FDA gives fast-track status to Pfizer and Arvinas' breast cancer drug

08-Feb-2024 - Last updated on 08-Feb-2024 at 11:58 GMT

A small molecule oral treatment for breast cancer has been granted fast-track designation by the US Food and Drug Administration (FDA).

Vepdegestrant is a novel oral PROteolysis Targeting Chimera (PROTAC) ER degrader specifically for estrogen receptor-positive and HER2-negative metastatic breast cancer previously treated by endocrine-based therapy that is being jointly developed by Arvinas and Pfizer.

Being developed jointly by Arvinas and Pfizer, the drug candidate is a heterobifunctional PROTAC (proteolysis-targeting chimera) and selective estrogen receptor degrader (SERD) acts by targeting estrogen receptor alpha and cereblon (CRBN).

Vepdegestrant is a novel oral PROteolysis Targeting Chimera (PROTAC) ER degrader that is being jointly developed by Arvinas and Pfizer.

Chairperson, CEO, and president of Arvinas, John Houston, said: “We are focused on the persisting unmet needs of people with ER+/HER2- breast cancer and doing all that we can to expedite the development of vepdegestrant as a novel, oral ER-targeted potential therapy for this patient community,”

“We are pleased the FDA has granted Fast Track designation for vepdegestrant, and we continue to believe this investigational drug has the potential to harness the body’s own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins."

As described by the FDA, ‘fast track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need'.

Arvinas' John Houston

The purpose is to get important new drugs to patients earlier. Vepdegestrant as a monotherapy is being studied in the ongoing Phase 3 VERITAC-2 clinical trial, which is evaluating vepdegestrant or fulvestrant in patients with locally advanced or metastatic ER+/HER2- breast cancer who have been previously treated with an endocrine-based therapy.

“The receipt of 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,” said Roger Dansey, doctor of medicine, chief development officer, oncology, Pfizer.

“We are proud to continue our legacy of developing innovative treatment options for people impacted by metastatic breast cancer and look forward to working with the FDA as we advance our development program for vepdegestrant.”

This secondary breast cancer is a type that has spread beyond the breast and nearby lymph nodes to other parts of the body.

Hormone receptor positive (ER positive) HER2 negative metastatic breast cancer indicates that cancer cells grow in response to the hormones estrogen and progesterone but not in response to the protein HER2.

It is possible to be initially diagnosed with metastatic breast cancer called ‘de novo metastasis’ but it is more common to develop metastatic disease after having previously had surgery to treat a localised breast cancer.