Merck & Co. has received approval from the US Food and Drug Administration (FDA) for a new indication for its immuno-oncology drug, Keytruda (pembrolizumab), for patients with recurrent or metastatic head and neck squamous cell carcinoma with disease progression on or after platinum-containing chemotherapy. Keytruda is poised by some analysts for blockbuster status. It had 2015 sales of $566 million.

Keytruda is a humanized monoclonal antibody that increases the ability of the body's immune system to help detect and fight tumor cells. Keytruda is also indicated  for patients with unresectable or metastatic melanoma and for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test with disease progression on or after platinum-containing chemotherapy.

In related news, Merck has received approval from the European Commission (EC) for a new indication in which Keytrudua can be used to treat locally advanced or metastatic NSCLC in patients whose tumors express PD-L1 and who have received at least one prior chemotherapy regimen. Patients with epidermal growth factor receptor or anaplastic lymphoma kinase-positive tumor mutations should also have received approved therapy for these mutations prior to receiving Keytruda. The EC approval allows marketing of Keytruda in all 28 European Union member states.

Source: Merck