WHITEHOUSE STATION (dpa-AFX) - Merck & Co Inc. (MRK) announced Monday that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency or EMA has adopted a positive opinion recommending approval of KEYTRUDA (pembrolizumab), the company's anti-PD-1 therapy.
The drug's positive opinion is for the treatment of locally advanced or metastatic non-small cell lung cancer or NSCLC in adults whose tumors express PD-L1 and who have received at least one prior chemotherapy regimen. The CHMP positive opinion for KEYTRUDA will now be reviewed by the European Commission for marketing authorization in the European Union.
On June 16, Merck announced that KEYTRUDA demonstrated superior progression-free and overall survival compared to chemotherapy as first-line treatment in patients with advanced NSCLC.
KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.
Merck said the data supporting the CHMP positive opinion were based on findings from two studies, KEYNOTE-010, a pivotal study assessing overall survival and KEYNOTE-001, which assessed overall response rates.
Based on this recommendation, a final decision regarding the approval of KEYTRUDA monotherapy is expected from the European Commission in the third-quarter of 2016.
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