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European Commission

In Europe, Blueprint will commercialize the drug first in Germany as a treatment for advanced GIST patients with a PDGFRA D842V mutation.

The commission took the earlier CHMP recommendation to approve the treatment based on the positive results from the Phase III SOLAR-1 trial.

The European Commission will review CHMP's recommendation and issue a decision on marketing authorization for the drug by the end of September.

The approval will make Merck and AstraZeneca's Lynparza available to patients in the EU who have not progressed after 16 weeks on platinum-based chemotherapy.

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 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.