Merck’s Keytruda gets expanded label for skin cancer treatment
Keytruda is already one of best-selling drugs in world
Merck announced Tuesday that the FDA approved an expanded label for Keytruda to treat patients with certain skin cancer that is not curable by surgery or radiation. The approval follows a Phase 2 KEYNOTE-629 clinical trial that enrolled patients with locally advanced cutaneous squamous cell carcinoma (cSCC).
The trial saw patients receive Keytruda 200 mg intravenously every three weeks until documented disease progression, unacceptable toxicity or a maximum of 24 months. Assessment of tumor status was performed every six weeks during the first year and every nine weeks during the second year. The objective response rate (ORR) was 50%, including a complete response rate of 17% and a partial response rate of 33% in the cohort of patients with locally advanced disease. Among the 27 responding patients, 81% had a duration of response (DOR) of six months or longer, and 37% had a DOR of 12 months or longer.
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Keytruda is one of the best-selling drugs worldwide, generating around $14.4 billion in revenue for Merck in 2020.
| Ticker | Security | Last | Change | Change % |
|---|---|---|---|---|
| MRK | MERCK & CO. INC. | 101.64 | -1.48 | -1.44% |
"This approval is great news for these patients and further demonstrates Merck’s commitment to the skin cancer community," Dr. Vicki Goodman, vice president of clinical research Merck Research Laboratories, said in a news release. "Keytruda has shown meaningful efficacy in patients with locally advanced ore recurrent or metastatic cutaneous squamous cell carcinoma that cannot be cured by surgery or radiation. This expanded indication reinforces the role of Keytruda in this cancer type, which is the second most common form of non-melanoma skin cancer."
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According to the American Cancer Society, skin cancer is by far the most common type of cancer, but nearly all can be treated effectively if found early. CSCC is the second most common form of skin cancer, and five times more prevalent than melanoma, according to the Skin Cancer Foundation.
FOX Business' Ann Schmidt contributed to this report.