EMA Gives Roche’s Alecensa Stamp of Approval as First-Line Treatment
A European Medicines Agency panel recommended Roche’s Alecensa as a first-line mutated lung cancer treatment Friday.
The EMA’s Committee for Medicinal Products for Human Use endorsed the drug for adults as an initial monotherapy against ALK positive non-small cell lung cancer. Final approval rests with the European Commission, but the commission generally follows the CHMP’s recommendations.
The Swiss company is still awaiting first-line approval for the drug in the United States. It was awarded priority review by the FDA in August.