Expanded indication approved in Europe for Keytruda

The European Commission has approved Keytruda (pembrolizumab) for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in adults whose tumors have high PD-L1 expression (tumor proportion score [TPS] of 50% or more) with no EGFR or ALK positive tumor mutations, US pharma giant Merck & Co (NYSE: MRK), the drug’s maker, reported this morning.

“The approval of Keytruda as a first treatment instead of chemotherapy for patients who express high levels of PD-L1 has the potential to transform the way metastatic non-small cell lung cancer is treated,” said Dr Roy Baynes, senior vice president, head of clinical development, and chief medical officer, Merck Research Laboratories.

Apart from lung cancer, Keytruda is approved in the USA for the treatment of patients with unresectable or metastatic melanoma until disease progression or unacceptable toxicity, and previously treated recurrent or metastatic head and neck cancer (HNSCC).

Label expansion will contribute to Merck’s top line, say analysts