EU Medicines Agency Panel Issues Positive Opinion on SFL Pharmaceuticals' Lung Cancer Drug Gevalka

08:02 AM EDT, 09/18/2026 (MT Newswires) -- A committee under the European Medicines Agency recommended granting marketing authorization for Gevalka as a treatment for adults with anaplastic lymphoma kinase, or ALK-positive, advanced non-small cell lung cancer, or NSCLC. Gevalka, submitted for approval by SFL Pharmaceuticals Deutschland, contains the active substance ensartinib and will be available in 25-milligram and 100-mg capsules, according to a Friday release. In a study of adults with locally advanced or metastatic ALK-positive NSCLC, the drug demonstrated an improvement in progression-free survival in the first-line setting. Following the Committee for Medicinal Products for Human Use's positive opinion, the European Commission will now make its decision on the treatment based on the recommendation.