European Commission

The approval presents another treatment option for the 3 percent to 5 percent of metastatic NSCLC patients with ALK rearrangements.

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 cancer immunotherapy regimen and companion diagnostic test will be available in Europe for patients with triple-negative breast cancer who express PD-L1.