The European Medicines Agency (EMA) has accepted a marketing authorisation application (MAA) for Astellas and Seagen’s enfortumab vedotin.
Astellas/Seagen’s MAA is seeking authorisation of enfortumab vedotin for the treatment of adult patients with locally advanced or metastatic urothelial (bladder) cancer, who have received a PD-1 or PD-L1 inhibitor and a platinum-based chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting.
The EMA will review enfortumab vedotin under an accelerated assessment pathway, which means the Committee for Medicinal Products for Human Use (CHMP) can cut the time of the evaluation.
The MAA is based on the Phase III EV-301 trial, which evaluated enfortumab vedotin versus chemotherapy in adult patients with locally advanced or metastatic urothelial cancer, who were previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor.
Results showed that overall survival was longer in the enfortumab vedotin group compared to the chemotherapy group – with a median overall survival of 12.88 months versus 8.97 months, respectively.
“People with advanced urothelial cancer face an urgent need for new treatment options, which is reflected in the CHMP’s decision to grant accelerated assessment,” said Andrew Krivoshik, senior vice president and oncology therapeutic area head, Astellas.
“We will continue to work with the CHMP toward our goal of securing marketing authorisation as soon as possible,” he added.
