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

Merck Sharp and Dohme's Keytruda has been recommended for European regulatory approval in a new lung cancer indication.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending approval of Keytruda for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in adults whose tumours have high PD-L1 expression, with no EGFR or ALK-positive tumour mutations.

Data from the KEYNOTE-024 study demonstrated that the drug was associated with superior overall and progression-free survival compared to chemotherapy in this patient group.

A final decision is expected from the European Commission in the first quarter of 2017.

Dr Roger Dansey, senior vice-president and therapeutic area head for oncology late-stage development at Merck Research Laboratories, said: "We are committed to working collaboratively with governments and other stakeholders to ensure that Keytruda will be made available to patients in Europe as quickly as possible."

The drug is currently approved in Europe for the second-line treatment of patients with locally advanced or metastatic NSCLC whose tumours express PD-L1 and who have received at least one prior chemotherapy regimen. Patients with EGFR or ALK-positive tumour mutations should also have received targeted therapy before receiving Keytruda.

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