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ImmunoGen Confirms Approval of Kadcyla by FDA

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ImmunoGen, 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 taxane chemotherapy.

“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.”

Posted-In: News FDA


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