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CHMP Updates - November'25
- Oncofocus Team
- Nov 19, 2025
- 1 min read
Highlights from the CHMP Nov 2025 Meeting are out!
New Medicines
💊 Eli Lilly and Company's imlunestrant (Inluriyo: brain-penetrant oral ERα degrader) is indicated as monotherapy for the treatment of adult patients with ER+ve, HER2-ve, locally advanced or metastatic breast cancer with an activating ESR1-mutation, who have disease progression following prior treatment with an endocrine based regimen.
New Hybrid Medicines
💊 Accord Healthcare's enzalutamide (Enzalutamide Accordpharma, a generic and hybrid of Xtandi: AR signaling inhibitor) is indicated:
➤ As monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high-risk biochemical recurrent (BCR) non-metastatic hormone-sensitive prostate cancer (nmHSPC) who are unsuitable for salvage-radiotherapy.
➤ In combination with androgen deprivation therapy for the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC).
➤ For the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC).
➤ For the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.
➤ For the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.
Indication Expansions
💊 Incyte's tafasitamab (Minjuvi; anti-CD19) is indicated in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) (Grade 1-3a) after at least one line of systemic 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.
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