Another indication approved by FDA for Keytruda

There was more good news for Merck & Co (NYSE: MRK), with the US Food and Drug Administration approving its top-selling immuno-oncology drug Keytruda (pembrolizumab), under priority review, for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC).

Pembrolizumab was approved for use in combination with platinum and fluorouracil (FU) for all patients and as a single agent for patients whose tumors express PD‑L1 (Combined Positive Score [CPS] ≥1) as determined by an FDA-approved test.

The agency approved Keytruda in 2016 for recurrent/metastatic HNSCC that has progressed on or after platinum-based chemo. For its full current range of indications, Keytruda notched up sales of $2.27 billion in first-quarter 2019, up 55% year-on-year.