FDA Accepts NDA for Vepdegestrant in ER+/HER2- Advanced Breast Cancer Treatment.

Arvinas and Pfizer announced that the FDA has accepted the NDA for vepdegestrant for treating ESR1m, ER+/HER2- advanced breast cancer. The filing is based on the Phase 3 VERITAC-2 clinical trial, which demonstrated statistically significant and clinically meaningful improvement in median progression-free survival compared to fulvestrant. Vepdegestrant is the first PROteolysis TArgeting Chimera (PROTAC) to demonstrate clinical benefit in breast cancer patients.

The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for vepdegestrant, an investigational oral PROTAC ER degrader developed by Arvinas and Pfizer, for the treatment of patients with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-), ESR1-mutated advanced or metastatic breast cancer who have previously received endocrine-based therapy. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of June 5, 2026.

The NDA submission is based on data from the VERITAC-2 clinical trial, a global, randomized Phase 3 study evaluating vepdegestrant versus fulvestrant. The trial demonstrated statistically significant and clinically meaningful improvement in median progression-free survival (PFS) compared to fulvestrant. Notably, vepdegestrant is the first PROteolysis TArgeting Chimera (PROTAC) to show clinical benefit in breast cancer patients [1].

Arvinas, a clinical-stage biotechnology company, is dedicated to developing protein degradation therapies for debilitating and life-threatening diseases. Vepdegestrant, developed through Arvinas' PROTAC platform, targets the estrogen receptor and is being co-developed and co-commercialized with Pfizer. The collaboration was announced in July 2021, and the companies will share worldwide development costs, commercialization expenses, and profits.

The VERITAC-2 trial enrolled 624 patients, 270 of whom had ESR1 mutations, at 213 sites in 25 countries. Patients were randomized 1:1 to receive either vepdegestrant or fulvestrant. The primary endpoint was PFS in the ESR1-mutation and intent-to-treat populations, with overall survival as the key secondary endpoint.

The FDA's acceptance of the NDA for vepdegestrant marks a significant milestone in breast cancer treatment, particularly for patients with ESR1-mutated ER+/HER2- advanced breast cancer, a challenging condition with limited second-line treatment options. The approval of vepdegestrant could provide a meaningful new treatment option for this patient population.

References:
[1] https://finance.yahoo.com/news/arvinas-announces-fda-acceptance-drug-200500022.html