CHMP Updates - May'25

Highlights from the CHMP May 2025 Meeting are out!

⭐ New Medicines

💊 Autolus Therapeutics' obecabtagene autoleucel (Aucatzyl; CD19 CAR-T cell therapy) for the treatment of adults from 26 years of age with R/R B cell precursor acute lymphoblastic leukaemia

👉 Positive opinion recommending the granting of a conditional marketing authorisation

💊 GSK's belantamab mafodotin (Blenrep; anti-BCMA ADC) for the treatment of adults with R/R multiple myeloma:

👉In combination with bortezomib and dexamethasone in patients who have received at least one prior therapy

👉In combination with pomalidomide and dexamethasone in patients who have received at least one prior therapy including lenalidomide

💊 Roche's inavolisib (Itovebi; PI3Kα inhibitor) in combination with Pfizer's palbociclib (CDK 4/6 inhibitor) and fulvestrant (estrogen receptor antagonist) for the treatment of adult patients with PIK3CA‑mutated, ER+ve, HER2‑ve, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment

⭐ New Biosimilars

💊 Fresenius Kabi Deutschland's denosumab biosimilar (Bomyntra; anti-RANKL) intended for the prevention of skeletal-related events in adults with advanced malignancies involving bone and the treatment of adults and skeletally mature adolescents with giant cell tumour of bone

⭐ Indication Expansions

💊 AstraZeneca's durvalumab (Imfinzi; anti-PD-L1) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by durvalumab monotherapy as adjuvant treatment after radical cystectomy for adults with resectable muscle invasive bladder cancer

💊 BeiGene’s tislelizumab (Tevimbra; anti PD-1) in combination with gemcitabine and cisplatin for the first-line treatment of adult patients with recurrent, not amenable to curative surgery or radiotherapy, or metastatic nasopharyngeal carcinoma

👉 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-19-22-may-2025