logo
Plus   Neg
Share
Email

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.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Fast-food giant McDonald's said it will be raising hourly wages for more than 36,500 hardworking employees at McDonald's-owned restaurants by an average of 10 percent to make it among the industry-leading pay and benefits package. These increases, which have already begun, will be rolled out over the next several months. Biogen Inc. (BIIB) Friday said its XIRIUS study of cotoretigene toliparvovec failed to meet its primary endpoint in Phase 2/3 in patients with X-linked retinitis pigmentosa or XLRP. The company further noted that the study obtained positive trends in other pre-specified clinically relevant endpoints,... General Mills Inc. (GIS) agreed to buy Tyson Foods' (TSN) pet treats business for $1.2 billion in cash, the companies said in a statement on Friday. The transaction includes the Nudges, Top Chews and True Chews brands. General Mills will also acquire a manufacturing facility in Independence, Iowa.
Follow RTT