ImmunoGen, Inc. Announces FDA Has Granted Priority Review Status to the Trastuzumab Emtansine (T-DM1) Marketing Application
November 06 2012 - 3:30PM
Business Wire
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 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.
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