CHMP Updates - February'25

Highlights from the CHMP Feb 2025 Meeting are out! Here are the positive recommendations in the Oncology space:

⭐ New Therapies:

👉 Regeneron's linvoseltamab (BCMA x CD3 BsAb) mono for the treatment of adult patients with R/R multiple myeloma who have received at least 3 prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38, and have demonstrated disease progression on the last therapy

⭐ Indication expansions:

👉 AstraZeneca's acalabrutinib (selective BTK inhibitor) mono for the treatment of adult patients with relapsed or refractory mantle cell lymphoma not previously treated with a BTK inhibitor

👉 Roche's glofitamab (CD20 x CD3 BsAb) + gemcitabine + oxaliplatin for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified who are ineligible for autologous stem cell transplant

👉 Janssen's daratumumab (anti-CD38) + bortezomib (proteasome inhibitor) + lenalidomide (thalidomide analogue) + dexamethasone (glucocorticoids) for the treatment of adult patients with newly diagnosed multiple myeloma regardless of eligibility for ASCT

👉 AstraZeneca & Daiichi's trastuzumab deruxtecan (HER2 ADC) mono for the treatment of adult patients with unresectable or metastatic HR+ve, HER2-low or HER2-ultralow breast cancer who have received at least one endocrine therapy in the metastatic setting and who are not considered suitable for endocrine therapy as the next line of treatment

👉 AstraZeneca's duvalumab (anti-PD-L1) + platinum-based chemo as neoadjuvant treatment, followed by durvalumab monotherapy as adjuvant treatment for adults with resectable NSCLC at high risk of recurrence and no EGFR mutations or ALK rearrangements

👉 Lilly's pirtobrutinib (selective BTK inhibitor) mono for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukaemia who have been previously treated with a BTK inhibitor

⭐ New Generic Medicine:

👉 Accord Healthcare's trabectedin (chemotherapy) for the treatment of adult patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents

👉 Trabectedin + pegylated liposomal doxorubicin for the treatment of patients with relapsed platinum-sensitive ovarian cancer

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-24-27-february-2025