By Colin Kellaher
Merck & Co. has won U.S. Food and Drug Administration priority review for its application seeking expanded use of its blockbuster cancer drug Keytruda in certain patients with head and neck cancer.
The Rahway, N.J., drugmaker on Tuesday said the application covers Keytruda for the treatment of patients with resectable locally advanced head and neck squamous cell carcinoma as neoadjuvant treatment, then continued as adjuvant treatment in combination with standard-of-care radiotherapy with or without cisplatin, and then as a single agent.
The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period. Merck said the agency set a target action date of June 23 for its application.
The standard of care for patients with resectable locally advanced head and neck squamous cell carcinoma has remained the same for more than 20 years, representing a significant unmet need for new treatment options, Merck said, adding that it aims to reduce the risk of recurrence and disease progression in earlier stages of disease.
Merck is studying Keytruda, a cancer drug that harnesses a patient's immune system to fight tumors, in a raft of trials across a wide variety of cancers and treatment settings. The drug, which is approved in dozens of indications worldwide, generated sales of nearly $29.5 billion last year.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
February 25, 2025 07:22 ET (12:22 GMT)
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