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
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.
WALTHAM, Mass.--(BUSINESS WIRE)--
Inc. (Nasdaq: IMGN), a biotechnology
company that develops anticancer therapeutics using its TAP technology,
today announced that Roche has reported that the U.S. Food and Drug
Administration (FDA) has granted marketing approval to Kadcyla for the
treatment of people with HER2-positive metastatic breast cancer who have
received prior treatment with Herceptin® (trastuzumab) and a
"This is a big day for the patients with this cancer and for ImmunoGen,"
commented Daniel Junius, President and CEO. "In clinical testing, the
findings with Kadcyla in this patient population have been impressive,
and we're delighted the product can now be used by practicing
oncologists across the US. In addition to its importance from a medical
perspective, commercialization of Kadcyla also marks the start of
ImmunoGen earning royalty income."
Mr. Junius continued, "The efficacy and tolerability seen with Kadcyla
underscores the transformative potential of our technology. Kadcyla is
the most advanced of ten compounds with our TAP technology already in
the clinic, with more in earlier stages of development. We are hopeful
that in the future many different types of cancers will be routinely
treated with TAP compounds."
Kadcyla has gained FDA approval for the treatment of people with
HER2-positive metastatic breast cancer who have received prior treatment
with Herceptin and a taxane chemotherapy. People should either:
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.
FDA approval of Kadcyla triggers a $10.5 million milestone payment to
ImmunoGen. The Company also earns royalties on commercial sales of
Kadcyla. Genentech is prepared to launch the product imminently.
"I am thrilled to see our concept of a trastuzumab-DM1 conjugate become
a reality today," commented John Lambert, Ph.D., Executive Vice
President and Chief Scientific Officer. "We have always believed this
product could make an enormous difference for appropriate patients and
are delighted to see it move into the hands of practicing oncologists."
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,
Genentech licensed from ImmunoGen exclusive rights to use the Company's
maytansinoid TAP technology to develop anticancer products targeting
In 2006, Genentech advanced the compound that became known as Kadcyla
into clinical testing. Genentech has implemented a broad Kadcyla
clinical development program that has continued to expand subsequent to
Genentech's acquisition by Roche.
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
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
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
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 ImmunoGen, Inc.
ImmunoGen, Inc. develops targeted anticancer therapeutics. The Company's
TAP technology uses a tumor-targeting monoclonal antibody to deliver one
of ImmunoGen's highly potent cancer-killing agents specifically to tumor
cells. Ten TAP compounds are now in clinical testing, of which three are
wholly owned by the Company. The most advanced compound using
ImmunoGen's TAP technology, Kadcyla (formerly T-DM1) has been approved
for marketing in the US and is undergoing regulatory review in Europe
and Japan; it is being commercialized in the US by Genentech, a member
of the Roche Group. More information about ImmunoGen can be found at www.immunogen.com.
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 June 30, 2012 and
other reports filed with the Securities and Exchange Commission.
Herceptin® is a registered trademark of Genentech.
Kadcyla™ is a
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.
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