CHMP Updates - January'25

Highlights from the Committee for Medicinal Products for Human Use (CHMP) January 2025 Meeting are out! Here are the positive recommendations in the Oncology space (Ref 1):

⭐ New Therapies:

👉 AstraZeneca and Daiichi Sankyo's datopotamab deruxtecan (TROP2-directed ADC) for the treatment of adult patients with unresectable or metastatic HR-positive, HER2-negative breast cancer (post-endocrine therapy + chemo)

👉 Pfizer, Zai Lab, and Genmab's tisotumab vedotin (tissue factor-directed ADC) for the treatment of adult patients with recurrent or metastatic cervical cancer (post-systemic therapy)

⭐ Indication Expansions:

👉 BMS' lisocabtagene maraleucel (CD19 CAR-T) for the treatment of adults with relapsed or refractory follicular lymphoma (after ≥2 lines of systemic therapy)

👉 AstraZeneca's durvalumab (anti-PD-L1) for the treatment as monotherapy of adults with limited-stage small cell lung cancer whose disease has not progressed following CRT

👉 BMS' nivolumab (anti-PD-1) + ipilimumab (anti-CTLA-4) for the first‑line treatment of adult patients with unresectable or advanced hepatocellular carcinoma

Looking for more details on these recommendations, their registrational trial designs and outcomes, and impact on the landscape? Reach out to us at support@oncofocus.com.

🌐 Reference: https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-27-30-january-2025