At its January 2025 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorisation for four new medicines and expanded indications for eight.
The new medicines include AstraZeneca/Daiichi Sankyo’s Datroway® (datopotamab deruxtecan) for patients with unresectable or metastatic hormone receptor (HR)-positive, HER2- negative breast cancer who have received endocrine therapy and at least an additional line of chemotherapy in the advanced setting. Datroway® was approved in the US for the same indication in mid-January 2025 and in Japan in December 2024. However, in December 2024, AZ/Daiichi voluntarily withdrew their European marketing authorisation application for the NSCLC indication of Datroway® based on CHMP feedback. Daiichi Sankyo and AstraZeneca are jointly developing and commercialising the product pursuant to an agreement entered in July 2020, with Daiichi being the sponsor in Europe.
Pfizer’s Tivdak® (tisotumab vedotin) also received a positive opinion at the January CHMP meeting for treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy.
The eight CHMP-recommended indication expansions included those for AZ’s Imfinzi® (durvalumab), for treatment as monotherapy of adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy; BMS’ Opdivo® (nivolumab) in combination with Yervoy® (ipilimumab) for first line treatment of adult patients with unresectable or advanced hepatocellular carcinoma; and Roche’s Ronapreve® (casirivimab/imdevimab) for COVID-19 in children.
Three biosimilars received positive opinions from CHMP at the January meeting as reported here.