CHMP Updates - April'25

Highlights from the CHMP Apr 2025 Meeting are out!

⭐ New Medicines

💊 Jazz Pharmaceuticals and BeiGene's zanidatamab (Ziihera; dual HER2-targeted BsAb) monotherapy is indicated for the treatment of adults with unresectable locally advanced or metastatic HER2+ve biliary tract cancer previously treated with at least one prior line of systemic therapy

⭐ New Biosimilars

💊 CuraTeQ Biologics' trastuzumab (Dazublys; HER2 inhibitor) is indicated for the treatment of HER2+ve metastatic and early breast cancer

⭐ Indication Expansions

💊 Pfizer and Takeda's brentuximab vedotin (Adcetris; CD30 targeting ADC) is indicated for adult patients with previously untreated, CD30+ stage IIB with risk factors, stage III or stage IV Hodgkin lymphoma in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine, dexamethasone

💊 AstraZeneca's acalabrutinib (Calquence; BTK inhibitor) + venetoclax ± obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia

👉 Looking for more details on these recommendations, their registrational trial design and outcomes, and impact on the landscape? Reach out to us at support@oncofocus.com, and we will take it from there.

🌐 Reference: https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-22-25-april-2025