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Seagen : EMA Accepts MAA Of Enfortumab Vedotin For Urothelial Cancer Treatment

Astellas Pharma Inc. and Seagen Inc. (SGEN) said that the European Medicines Agency or EMA accepted a marketing authorization application for enfortumab vedotin. Enfortumab vedotin will be reviewed under accelerated assessment for the treatment of locally advanced or metastatic urothelial cancer.

If approved, enfortumab vedotin would be the first antibody-drug conjugate available in the European Union for people living with urothelial cancer, the companies said in a statement.

The marketing authorization application requests review of enfortumab vedotin for the treatment of adult 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.

Astellas and Seagen are co-developing enfortumab vedotin under a 50:50 worldwide development and commercialization collaboration.

In the United States, the companies co-promote enfortumab vedotin under the brand name PADCEV or enfortumab vedotin-ejfv. In the Americas outside the US, Seagen holds responsibility for commercialization activities and regulatory filings. Outside of the Americas, Astellas holds responsibility for commercialization activities and regulatory filings.

Urothelial cancer is the most common type of bladder cancer (90 percent of cases), 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.

Locally advanced and metastatic urothelial cancer is an aggressive disease that is associated with poor survival and high healthcare costs.

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