CHMP Updates - June'26

Highlights from the CHMP June 2026 Meeting are out!

New Biosimilar Medicines

💊 Ascend GmbH & Enzene Biosciences Ltd's denosumab (Denosumab Ascend; anti-RANKL) is intended for the prevention of bone complications in adults with advanced cancer involving bone and for the 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

💊 AstraZeneca and Daiichi Sankyo US' datopotamab deruxtecan (Datroway; Trop-2 ADC) as monotherapy is indicated for the first-line treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy

💊 Eli Lilly and Company's pirtobrutinib (Jaypirca; BTK inhibitor) as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL)

💊 Johnson & Johnson Innovative Medicine's teclistamab (Tecvayli; BCMA x CD3 bispecific antibody) is indicated in combination with daratumumab (anti-CD38) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior therapy

👉 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-june-2026