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 kristin.jones@dowjones.com
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