Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Kadcyla (trastuzumab emtansine) for the adjuvant (after surgery) treatment of adult patients with HER2-positive early breast cancer (eBC) who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant (before surgery) taxane-based and HER2-targeted therapy.

Based on this recommendation, a final decision regarding approval of Kadcyla in this setting, along with the full details of the approved indication, is expected from the European Commission in the near future.

'In the early breast cancer setting where cure is achievable, it is important to do everything possible to prevent progression to an advanced, incurable stage.' said Levi Garraway, MD PhD, Roche's Chief Medical Officer and Head of Global Product Development. 'This recommendation therefore marks a significant step forward in bringing a potentially transformative treatment option to patients in Europe with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant therapy.'

The recommendation from the CHMP is 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 (invasive disease-free survival; iDFS) by 50% (HR=0.50, 95% CI 0.39-0.64, p

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