CHMP Updates - July'25

Highlights from the CHMP July 2025 Meeting are out!

New Medicines

💊 Servier's vorasidenib (Voranigo; IDH1/2 inhibitor) monotherapy for the treatment of predominantly non-enhancing Grade 2 astrocytoma or oligodendroglioma with an IDH1 R132 or IDH2 R172 mutation in adult and adolescent patients aged 12 years and older and weighing at least 40 kg who only had surgical intervention and are not in immediate need of radiotherapy or chemotherapy

New Biosimilars

💊 Henlius' denosumab (Bilprevda; anti-RANKL) for prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone, and treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity

Indication Expansions

💊 BeOne Medicines’ tislelizumab (Tevimbra; anti PD-1) in combination with platinum-containing chemotherapy as neoadjuvant treatment and then continued as monotherapy as adjuvant treatment for adult patients with resectable NSCLC at high risk of recurrence

👉 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-21-24-july-2025