ImmunoGen, Inc. Announces FDA Approval of Kadcyla (Ado-Trastuzumab Emtansine; Also Known as T-DM1)
- Product demonstrates the power of ImmunoGen's Targeted Antibody Payload (TAP) technology — first antibody-drug conjugate approved for a solid tumor indication.
-
Compound to be marketed in the US by
Genentech , a member of the Roche Group, under the brand name Kadcyla™; was previously referred to as T-DM1. -
FDA approval triggers$10.5 million milestone payment to ImmunoGen; paves way for royalties on commercial sales. - Three wholly owned ImmunoGen TAP compounds advancing in clinic along with six additional partner TAP compounds.
"This is a big day for the patients with this cancer and for ImmunoGen,"
commented
Kadcyla has gained
- Have already been treated for their metastatic cancer, or
- Have had their early-stage cancer come back during or within six months after they completed a course of treatment following surgery.
"I am thrilled to see our concept of a trastuzumab-DM1 conjugate become
a reality today," commented
Collaboration History
ImmunoGen conceived of the idea of attaching the Company's DM1
maytansinoid cell-killing agent to Genentech's trastuzumab antibody to
achieve a highly effective, HER2-targeted anticancer agent. In 2000,
In 2006,
Today, multiple Phase III trials are underway or planned evaluating Kadcyla for a number of HER2-positive breast cancer indications. The compound also is being evaluated for the treatment of HER2-positive gastric cancer.
Multiple TAP Compounds Advancing in the Clinic
In addition to Kadcyla, nine other compounds with the Company's TAP technology are in clinical testing for the treatment of an array of cancer types. Three of these compounds are wholly owned by ImmunoGen:
- IMGN901, in Phase II testing for the treatment of small-cell lung cancer;
- IMGN853, in Phase I testing for the treatment of ovarian, lung, and other cancers that over-express folate receptor 1; and
- IMGN529, in Phase I testing for the treatment of non-Hodgkin's lymphoma.
The Company expects to advance a fourth TAP compound, IMGN289, into the clinic in 2013. IMGN289 targets EGFR and is a potential treatment for cancers that overexpress this target, including many head and neck and non-small cell lung cancers.
About
This press release includes forward-looking statements. For these
statements, ImmunoGen claims the protection of the safe harbor for
forward-looking statements provided by the Private Securities Litigation
Reform Act of 1995. It should be noted that there are risks and
uncertainties related to the development of novel anticancer products,
including risks related to preclinical and clinical studies, their
timings and results. A review of these risks can be found in ImmunoGen's
Annual Report on Form 10-K for the fiscal year ended
Herceptin® is a registered trademark of
Kadcyla™ is a
trademark of
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