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.
Collaboration HistoryImmunoGen 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 HER2. 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 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.