Arvinas and Pfizer’s vepdegestrant (ARV-471) has received Fast Track Designation from the US Food and Drug Administration (FDA) for the treatment of patients with ER+/HER2- metastatic breast cancer.
Vepdegestrant is an investigational PROteolysis Targeting Chimera (PROTAC) protein degrader designed to target and degrade the estrogen receptor (ER) protein.
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.
The companies were awarded a UK Innovation Passport for vepdegestrant in August 2023.
Vepdegestrant as a monotherapy is being studied in the ongoing Phase III 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.
It is also being investigated in another Phase III trial, VERITAC-3, in the first-line setting in combination with Palbociclib, and for potential combination therapy with abemaciclib, ribociclib, samuraciclib, everolimus, and with Pfizer’s investigational novel CDK4 inhibitor, PF-07220060.
In preclinical studies, vepdegestrant demonstrated up to 97% ER degradation in tumour cells, induced robust tumour shrinkage when dosed as a single agent in multiple ER-driven xenograft models, and showed increased anti-tumour activity when compared to a standard of care agent, fulvestrant, both as a single agent and in combination with a CDK4/6 inhibitor.
“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,” said John Houston, Arvinas Chairperson, Chief Executive Officer, and President. “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.”