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CHMP Updates - June'25
- Oncofocus Team
- 4 days ago
- 2 min read
Highlights from the CHMP May 2025 Meeting are out!
New Medicines
💊 Cordex Biologics' (an ExCellThera company) dorocubicel (Zemcelpro; UM171 Cell Therapy) has been recommended for a conditional marketing authorisation for the treatment of adult patients with haematological malignancies requiring an allogeneic haematopoietic stem cell transplantation following myeloablative conditioning for whom no other type of suitable donor cells is available.
Indication Expansions
💊 Exelixis, Ipsen and Takeda's cabozantinib (Cabometyx; multiple tyrosine kinase inhibitor) is indicated for the treatment of adult patients with unresectable or metastatic, well differentiated extra-pancreatic (epNET) and pancreatic (pNET) neuroendocrine tumours who have progressed following at least one prior systemic therapy other than somatostatin analogues.
💊 Johnson & Johnson Innovative Medicine's daratumumab (Darzalex; anti-CD38) monotherapy is indicated for the treatment of adult patients with smouldering multiple myeloma at high risk of developing multiple myeloma.
💊 Johnson & Johnson Innovative Medicine and AbbVie's ibrutinib (Imbruvica; BTK inhibitor) in combination with Roche's rituximab (anti-CD20 mAb), cyclophosphamide, doxorubicin, vincristine, and prednisolone (Imbruvica + R-CHOP) alternating with R-DHAP (or R-DHAOx) without Imbruvica, followed by Imbruvica monotherapy, is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who would be eligible for autologous stem cell transplantation (ASCT).
💊 Bayer and Orion Pharma darolutamide (Nubeqa; oral androgen receptor inhibitor) in combination with androgen deprivation therapy is indicated for the treatment of adult men with hormone-sensitive metastatic prostate cancer.
💊 Sanofi's isatuximab-irfc (Sarclisa; anti-CD38) in combination with bortezomib, lenalidomide, and dexamethasone is indicated for the induction treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.
👉 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.
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