The European Medicines Agency’s advisory group CHMP has adopted a positive opinion backing the use of Roche’s (OTCQX:RHHBY) Kadcyla (trastuzumab emtansine) as monotherapy for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual disease in the breast and/or lymph nodes after neoadjuvant taxane-based and HER2-targeted therapy.
Kadcyla is currently approved in the EU for adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination.
A final decision usually takes ~60 days.
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