Astellas Pharma and Seagen cancer treatment gets MAA acceptance from EMA
Astellas Pharma and Seagen Inc. have announced that the EMA has accepted their marketing authorisation application (MAA) for enfortumab vedotin, which will be used to treat patients with locally advanced or metastatic urothelial cancer (UC).
The MAA is based on a Phase III EV-301 trial that evaluated enfortumab vedotin versus chemotherapy in adult patients with locally advanced or metastatic UC who were previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor. The successful results of this trial were published on 25 March on The New England Journal of Medicine.
The MAA requests the review of enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer who have received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and who have received a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting.
If approved, enfortumab vedotin would be the first antibody-drug conjugate (ADC) available in the EU for people living with UC.
UC is the most common type of bladder cancer, and can also be found in the renal pelvis (where urine collects inside the kidney), ureter (tube that connects the kidneys to the bladder) and urethra. Globally, approximately 549,000 new cases of bladder cancer and 200,000 deaths are reported annually.
Enfortumab vedotin will be reviewed under accelerated assessment, which means the EMA’s Committee for Medicinal Products for Human Use (CHMP) can reduce the timeframe for evaluation.
Andrew Krivoshik, Senior Vice President and Oncology Therapeutic Area Head at Astellas, said: “In the EU, it is estimated that 118,000 people are diagnosed with urothelial cancer each year, and 52,000 die as a result of the disease.
“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. We will continue to work with the CHMP toward our goal of securing marketing authorization as soon as possible.”
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