Attenzione! Il presente contenuto è disponibile solo in lingua originale.
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 |
|
Grazie per il tuo feedback!
