Merck & Co. said Tuesday that the FDA approved Keytruda (pembrolizumab) as monotherapy for the first-line treatment of patients with metastatic or unresectable, recurrent head and neck squamous cell carcinoma (HNSCC) whose tumours express PD-L1. The company noted that the agency also authorised the drug in combination with platinum and 5-fluorouracil as a first-line treatment for patients with metastatic or unresectable HNSCC regardless of PD-L1 expression.
The FDA previously granted accelerated approval to Keytruda for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy. According to Merck, the new approvals, which follow priority review designation in February, make Keytruda the first anti-PD-1 therapy authorised in the first-line setting as monotherapy in patients whose tumours express PD-L1 or in combination with chemotherapy regardless of PD-L1 expression for patients with metastatic or with unresectable, recurrent HNSCC.
The new indications are based on data from the Phase III KEYNOTE-048 trial, where Keytruda demonstrated a significant improvement in overall survival compared with standard treatment as monotherapy in patients whose tumours expressed PD-L1 and in combination with chemotherapy in the total study population. In the trial, final results from which were presented last month, Keytruda significantly prolonged overall survival, reducing the risk of death by 40 percent in patients whose tumours expressed PD-L1 with a combined positive score (CPS) of at least 20, and by 35 percent in those with a CPS of at least 1.
Sales of Keytruda in the first quarter surged 55 percent year-on-year to $2.3 billion, with revenue from the product estimated to exceed $10 billion this year and $20 billion in 2024. For related analysis, see ViewPoints: Key takeaways from Merck & Co.'s Q1 earnings and investor call.
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