Opinione favorevole del CHMP per crizotinib nel NSCLC positivo a ROS1

The Committee for Medicinal Products for Human Use (CHMP) has adopted a positive option for crizotinib as a treatment for adults with ROS1-positive advanced non–small cell lung cancer (NSCLC), suggesting an approval may be imminent. The positive opinion was based on findings from a phase I study, which included 50 patients with the rare alteration. In findings from the single-arm study that were published in The New England Journal of Medicine, crizotinib showed an overall response rate (ORR) of 66% with a median duration of response of 18.3 months by independent review. The positive … (leggi tutto)