CHMP adopts a positive opinion for Poherdy, a pertuzumab biosimilar for treatment of breast cancer – Organon

The Committee for Medicinal Products for Human Use (CHMP) of the EMA adopted a positive opinion, recommending the granting of a marketing authorisation for Poherdy in  combination with trastuzumab and chemotherapy in:  • the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence •  the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence  and •  Poherdy in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorisation has been granted by the European Commission.