CHMP Updates - March'26

Highlights from the CHMP Apr 2026 Meeting are out!

New Generics

💊 Viatris' palbociclib (Palbociclib Viatris; CDK4/6 inhibitor) for the treatment of HR+ HER2- locally advanced or metastatic breast cancer either in in combination with an aromatase inhibitor, or in combination with fulvestrant in women who have received prior endocrine therapy

Indication Expansions

💊 Otsuka Pharmaceutical Companies (U.S.)'s fixed‑dose oral combination of decitabine‑cedazuridine (Inaqovi; hypomethylating agent) in combination with venetoclax for the treatment of adult patients with newly diagnosed AML who are ineligible for standard induction chemotherapy

💊 Bristol Myers Squibb's nivolumab (Opdivo; anti-PD-1) in combination with doxorubicin, vinblastine and dacarbazine (AVD) for adults and adolescents 12 years of age and older with previously untreated stage III/IV classical Hodgkin lymphoma

💊 AbbVie & Roche's venetoclax (Venclyxto; selective BCL‑2 inhibitor) in combination with ibrutinib for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL)

💊 Venetoclax in combination with acalabrutinib with or without obinutuzumab for the treatment of adult patients with previously untreated CLL

👉 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-20-23-april-2026