ImmunoGen, Inc. Announces Positive Regulatory Decisions for Roche's Kadcyla® in the European Union and Japan
-
CHMP has issued a positive opinion for Kadcyla, with the
European Commission decision expected by the end of 2013. -
The Japanese MHLW has approved Kadcyla for marketing in
Japan , which triggers a $5 million milestone payment to ImmunoGen. - Kadcyla comprises Roche's trastuzumab antibody and ImmunoGen's ADC technology.
The EU's
"These positive decisions are important steps toward Kadcyla becoming
available for patients in the EU and Japan," commented
The EMILIA trial assessed Kadcyla compared to standard therapy for the treatment of patients with HER2-positive metastatic breast cancer who had previously received Herceptin® (trastuzumab) and a taxane. Kadcyla demonstrated a significant improvement in overall survival and in progression-free survival, and fewer patients experienced severe adverse events, compared to standard therapy.
Kadcyla consists of Roche's trastuzumab antibody and ImmunoGen's DM1 cytotoxic agent. The DM1 is attached to the antibody using one of ImmunoGen's linkers. Roche has global development and commercialization rights for Kadcyla; ImmunoGen is entitled to receive specified milestone payments and royalties on product sales.
Roche is conducting a number of studies assessing Kadcyla for potential additional uses. These include for the first-line treatment of HER2-positive metastatic breast cancer, for early stage HER2-positive breast cancer and for advanced HER2-positive gastric cancer.
About
Kadcyla® and Herceptin® are registered trademarks
of
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 regulatory decisions, 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
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