CHMP raccomanda l’approvazione di pembrolizumab nel tumore del polmone

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has granted a positive opinion for use of pembrolizumab (Keytruda) as a treatment for patients with locally advanced or metastatic PD-L1-positive non–small cell lung cancer (NSCLC) following at least 1 chemotherapy regimen. The recommendation is based on data from the KEYNOTE-010 and KEYNOTE-001 trials. Receiving the positive opinion suggests pembrolizumab is likely to be approved for this indication in the EU when the European Commission issues its final decision, which is expected by the third quarter of 2016. “This news marks … Leggi tutto