FDA Gives Priority Review to ImmunoGen, Roche Breast Cancer Drug

   By Kristin Jones 
 

The U.S. Food and Drug Administration has granted priority review to an investigational breast cancer treatment that is being developed by Genentech and ImmunoGen Inc. (IMGN), the companies said.

The drug, trastuzumab emtansine, is in global development by Roche Holding AG (RHHBY, RO.EB, ROG.VX) under an agreement between Roche unit Genentech and ImmunoGen.

Trastuzumab emtansine's proposed use is to treat people with an aggressive form of breast cancer, categorized as HER2-positive, that has metastasized or can't be removed with surgery.

ImmunoGen's technology uses monoclonal antibodies to deliver cancer-killing agents specifically to tumor cells.

Genentech said the FDA has confirmed an action date of Feb. 26, 2013.

"We're very pleased that the FDA has granted priority review" to the treatment, said ImmunoGen Chief Executive Daniel Junius. "This decision underscores the urgent need to have new and more effective treatment options available for patients with this cancer."

Genentech also said that Roche's marketing application to use trastuzumab emtansine to treat people with HER2-positive metastatic breast cancer has also been accepted for review by the European Medicines Agency.

ImmunoGen shares rose 4.3% in after-hours trading to $11.87. The stock is down 1.7% so far this year.

Roche's American depositary shares closed at $48.63 and were inactive after hours. The ADS are up 14% since the start of 2012.

Write to Kristin Jones at [e-mail]

Subscribe to WSJ: http://online.wsj.com?mod=djnwires