WALTHAM, Mass.--(BUSINESS WIRE)--
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 Marketing Authorization 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
Director, Investor Relations and Corporate Communications
The Yates Network
Barbara Yates, 781-258-6153
Source: ImmunoGen, Inc.
News Provided by Acquire Media