Merck Sharp and Dohme’s Keytruda recommended for lung cancer approval

Merck Sharp and Dohme has announced that its cancer therapy Keytruda has been recommended for EU approval in a new indication.

The Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending approval of Keytruda for the treatment of locally advanced or metastatic non-small cell lung cancer in adults whose tumours express PD-L1 and who have received at least one prior chemotherapy regimen.

This recommendation was based on positive data from two studies – KEYNOTE-010, a pivotal study assessing overall survival, and KEYNOTE-001, which assessed overall response rates.

Based on this ruling, a final decision regarding the approval of Keytruda monotherapy is expected from the European Commission in the third quarter of 2016.

Dr Roger Dansey, senior vice-president and therapeutic area head for oncology late-stage development at Merck Research Laboratories, said: "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 drug has already been approved as a treatment for metastatic non-small cell lung cancer by the US Food and Drug Administration.