CHMP Updates - January'26

Highlights from the CHMP Jan 2026 Meeting are out!

Indication Expansions

💊 Johnson & Johnson Innovative Medicine's niraparib & abiraterone acetate co-formulation (Akeega; PARP x CYP17 inhibitor) is indicated with prednisone or prednisolone in combination with androgen deprivation therapy (ADT) for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) and BRCA 1/2 mutations (germline and/or somatic)

💊 Incyte and Takeda's ponatinib (Iclusig; multi-target kinase inhibitor) is indicated in combination with reduced-intensity chemotherapy in adult patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL)

💊 AstraZeneca's durvalumab (Imfinzi; anti-PD-L1) in combination with FLOT chemotherapy as neoadjuvant and adjuvant treatment, followed by adjuvant durvalumab monotherapy, is indicated for the treatment of adults with resectable gastric or gastro‑oesophageal junction adenocarcinoma

💊 Bristol Myers Squibb's nivolumab (Opdivo; anti-PD-1) in combination with Pfizer & Takeda's brentuximab vedotin (CD30 targeting ADC) is indicated for the treatment of children 5 years of age and older, adolescents and adults up to 30 years of age with relapsed or refractory classical Hodgkin lymphoma after one prior line of therapy

💊 MacroGenics, Inc., Incyte & Zai Lab's retifanlimab (Zynyz; anti-PD-1) is indicated in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with metastatic or with inoperable locally recurrent squamous cell carcinoma of the anal canal (SCAC)

👉 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-26-29-january-2026