Posted by Michael Wonder on 06 Jun 2025
Arvinas announces submission of new drug application to US FDA for vepdegestrant for patients with ESR1 mutated ER+/HER2- advanced or metastatic breast cancer
6 June 2025 - Arvinas today announced the submission of a new drug application to the US FDA with its partner Pfizer for vepdegestrant for the treatment of patients with oestrogen receptor positive/human epidermal growth factor receptor 2 negative ESR1-mutated advanced or metastatic breast cancer previously treated with endocrine-based therapy.
This submission is based on results from VERITAC-2, a global, randomised Phase 3 trial evaluating vepdegestrant versus fulvestrant.
