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European Commission

The autologous treatment received conditional approval for relapsed or refractory mantle cell lymphoma patients based on results of the ZUMA-2 trial.

The combination treatment was approved for metastatic NSCLC patients without EGFR or ALK gene mutations and regardless of their PD-L1 status.

Regulators approved the PARP inhibitor as a monotherapy for BRCA1/2-mutated mCRPC and together with Avastin for advanced, HRD-positive ovarian cancer.

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.

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