Arvinas has received FDA approval for Veppanu (vepdegestrant), an oral heterobifunctional protein degrader for breast cancer.
Veppanu treats estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-), estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer. For patients to be eligible for treatment, progression must follow at least one line of endocrine therapy. It is the first proteolysis targeting chimera (PROTAC) to receive approval from the FDA.
Approval was granted before the PDUFA date based on data from the VERITAC-2 phase 3 trial, which compared the drug to fulvestrant. The trial showed statistically-significant progression-free survival, with a reduction in disease progression and death of 43% compared to fulvestrant.
After discovery by Arvinas, Veppanu was developed jointly by Arvinas and Pfizer. The next step is for the companies to choose a third-party partner to maximize the commercial potential of the drug.