EU expands approval for Roche's Kadcyla to include early HER2-positive breast cancer 

Roche said Thursday that the European Commission has approved Kadcyla (trastuzumab emtansine) for the adjuvant treatment of adults with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane-based and HER2-targeted therapy. The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion last month recommending approval of the drug.

The EU approval was based on results from the Phase III KATHERINE study, which showed that Kadcyla significantly reduced the risk of invasive breast cancer recurrence or death from any cause by 50% compared to Herceptin (trastuzumab) as an adjuvant treatment. After three years, 88.3% of patients treated with the antibody-drug conjugate did not have their breast cancer return versus 77% for Herceptin, representing an absolute improvement of 11.3%.

"This approval of Kadcyla will allow many more women with HER2-positive early breast cancer to be given a transformative treatment that may cut the risk of their disease returning or progressing," remarked Roche's chief medical officer Levi Garraway.

Kadcyla has been authorised in this setting in 27 countries, including the US and Canada, while a filing is pending in Japan. The therapy has also been approved in the US and EU for the treatment of patients with HER2-positive metastatic breast cancer who have previously received Herceptin and a taxane. 

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