Merck Gets CHMP Positive Opinion for KEYTRUDA for Advanced Non-Small Cell Lung Cancer Treatment

Merck & Co., Inc.

disclosed Monday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a favorable opinion and recommended KEYTRUDA for approval for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults. The drug is for patients whose tumors express PD-L1 and who have got a minimum of previous chemotherapy regimen. According to Merck, the CHMP positive opinion for KEYTRUDA would be reviewed by the European Commission now for marketing authorization in the European Union (EU). The company added that data supporting the CHMP positive opinion were based on findings from two trials, KEYNOTE-010 and KEYNOTE-001. The drug-maker's VP and Therapeutic Area Head, Oncology late-stage development, Roger Dansey, commented, "This news marks an important step in making KEYTRUDA available for appropriate patients suffering from locally advanced or metastatic non-small cell lung cancer. We are grateful to patients and investigators around the world who participated in these studies and who are helping to advance this important new treatment." The company disclosed that the CHMP recommended approval of KEYTRUDA monotherapy at a dose of 2 mg/kg every three weeks, which was also the FDA-approved dose for metastatic NSCLC in the America. Merck said that the recommendation would lead to a final decision on KEYTRUDA monotherapy approval, which is expected in the third quarter of the current year from the EU. Shares of the company traded 3.12 percent down on Friday.