This is the first anti-PD-1 drug approved for front-line treatment of advanced and unresectable, recurrent head and neck cancer in the EU.
The drug has shown in clinical trials to improve outcomes in patients with FLT3 internal tandem duplication and tyrosine kinase domain mutations.
The European Commission will review CHMP's recommendation and is slated to issue a final decision regarding marketing authorization later this year.
The cancer immunotherapy regimen and companion diagnostic test will be available in Europe for patients with triple-negative breast cancer who express PD-L1.
The PARP inhibitor is approved as a maintenance treatment for advanced ovarian cancer patients who responded to first-line platinum chemotherapy and have BRCA mutations.