CHMP positive for Enhurtu to treat metastatic HER2-positive breast cancer. - AstraZeneca + Daichi Sankyo.

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product Enhertu (trastuzumab deruxtecan), intended for the treatment of metastatic HER2-positive breast cancer. Enhertu was reviewed under EMA’s accelerated assessment programme. The applicant for this medicinal product is Daiichi Sankyo Europe GmbH.The benefits with Enhertu are improved objective response rate and duration of response in patients who had received two or more prior anti-HER2 based regimens. The most common side effects are nausea, fatigue, vomiting, alopecia, constipation, decreased appetite, anaemia, neutropenia, diarrhoea, thrombocytopenia, cough, leucopoenia and headache.