CHMP highlights (oncology) March 2025: Summary table

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CHMP highlights (oncology) March 2025: Summary table

Tradename (INN) Applicant/MAH Disease/condition Mechanism of action Links

Jubereq (denosumab)

Accord Healthcare S.L.U. Prevention of skeletal related events in adults with advanced malignancies involving bone Monoclonal antibody (IgG2) that targets and binds to RANKL, preventing the RANKL/RANK interaction from occurring and resulting in reduced osteoclast numbers and function, thereby decreasing bone resorption and cancer-induced bone destruction. Summary of opinion

Bosulif (bosutinib)

Pfizer Europe Ma EEIG Chronic myelogenous leukaemia (CML) Kinase inhibitor which inhibits the abnormal BCR ABL kinase that promotes CML. Summary of opinion

Calquence (acalabrutinib)

AstraZeneca AB Mantle cell lymphoma Bruton tyrosine kinase (BTK) inhibitor, a signalling molecule of the B-cell antigen receptor (BCR) and cytokine receptor pathways. In B-cells, BTK signalling results in B-cell survival and proliferation, and is required for cellular adhesion, trafficking, and chemotaxis. Summary of opinion

Opdivo (nivolumab)

Bristol-Myers Squibb Pharma EEIG Non-small cell lung cancer  Monoclonal antibody which binds to the programmed death-1 (PD-1) receptor, prevents its interaction with PD-L1 and PD-L2 and enhances anti-tumour responses, by stopping PD-1 from binding to its ligands. Summary of opinion

Tevimbra (tislelizumab)

BeiGene Ireland Ltd Small Cell Lung Cancer Monoclonal antibody which binds to the programmed death-1 (PD-1) receptor, prevents its interaction with PD-L1 and PD-L2 and enhances anti-tumour responses, by stopping PD-1 from binding to its ligands. Summary of opinion

Pemazyre (pemigatinib)

Incyte Biosciences Distribution B.V. Myeloid/lymphoid neoplasms  Kinase inhibitor of FGFR1, 2 and 3 which inhibits FGFR phosphorylation and signalling and decreases cell viability in cells expressing FGFR genetic alterations.  Q&A on refusal