ImmunoGen, Inc. Announces FDA Has Granted Priority Review Status to the
Trastuzumab Emtansine (T-DM1) Marketing Application
WALTHAM, Mass. -- November 06, 2012
ImmunoGen, Inc. (Nasdaq: IMGN), a biopharmaceutical company that develops
anticancer products using its Targeted Antibody Payload (TAP) technology and
antibody expertise, today announced that Genentech, a member of the Roche
Group, has disclosed that the U.S. Food and Drug Administration (FDA) has
officially accepted the Biologics License Application (BLA)for trastuzumab
emtansine and granted it Priority Review. The proposed indication is for the
treatment of people with HER2-positive, unresectable locally advanced or
metastatic breast cancer who have received prior treatment with Herceptin®
(trastuzumab) and a taxane chemotherapy. It also disclosed that Roche's
MarketingAuthorization Application for trastuzumab emtansine for people with
HER2-positive metastatic breast cancer has been accepted for review by the
European Medicines Agency.
“We’re very pleased that the FDA has granted Priority Review to the
trastuzumab emtansine BLA,” commented Daniel Junius, President and CEO. “This
decision underscores the urgent need to have new and more effective treatment
options available for patients with this cancer.”
The FDA grants Priority Review designation to drugs that may offer major
advances in treatment or provide a treatment where no adequate therapy exists.
For applications granted Priority Review, the FDA’s goal is to complete the
review and deliver a decision on marketing approval within six months. The FDA
has assigned this BLA a Prescription Drug User Fee Act (PDUFA) goal date of
February 26, 2013.
About ImmunoGen, Inc.
ImmunoGen, Inc. develops targeted anticancer therapeutics using the Company's
expertise in tumor biology, monoclonal antibodies, potent cancer-cell killing
agents and engineered linkers. The Company's TAP technology uses monoclonal
antibodies to deliver one of ImmunoGen's proprietary cancer-killing agents
specifically to tumor cells. There are now ten TAP compounds in clinical
development, of which three are wholly owned by the Company. Marketing
applications for trastuzumab emtansine (T-DM1), the most advanced compound
using ImmunoGen's TAP technology, are under review in the US and Europe. Roche
is developing this compound globally under an agreement between ImmunoGen and
Genentech, a member of the Roche Group. More information about ImmunoGen can
be found at www.immunogen.com.
Herceptin® is a registered trademark of Genentech.
Carol Hausner, 781-895-0600
Executive Director, Investor Relations and Corporate Communications
The Yates Network
Barbara Yates, 781-258-6153
Press spacebar to pause and continue. Press esc to stop.