FDA Approves Keytruda for Earlier Stage Melanoma Setting

Since 2011, the FDA has approved 10 therapies for advanced or late-stage melanoma. Recently the agency granted an additional approval to one of those drugs for the earlier stage melanoma setting.

On Dec. 3, the FDA approved Merck & Co., Inc.’s programmed death receptor-1 (PD-1) inhibitor Keytruda (pembrolizumab) for the adjuvant treatment of people at least 12 years old with stage IIB or IIC melanoma following complete resection. The agency also expanded the indication for the agent’s use as an adjuvant treatment of stage III melanoma following complete resection to include pediatric patients at least 12 years old.

According to the National Cancer Institute, melanoma of the skin is the fifth most common cancer. While melanomas can form in other parts of the body such as the eyes, mouth and genitals, the skin is the most common area.

In a statement, Jason Luke, M.D., F.A.C.P., director of the Cancer Immunotherapeutics Center at UPMC Hillman Cancer Center, pointed out that observation is the standard of care for people with resected stage IIB and IIC melanoma, but “the risk of recurrence is nearly the same as for patients with later-stage disease for whom treatment is recommended.” This new indication, he said, “is an important advance that provides these patients with a new option that can help reduce the risk of their cancer returning.”

For the Managed Care Oncology Index: Q1 2021, between Feb. 26, 2021, and April 9, 2021, Zitter Insights polled 100 oncologists. During the 12 months prior to the survey, Bristol Myers Squibb’s PD-1 inhibitor Opdivo (nivolumab) was prescribed most often, with 83% of respondents saying they had prescribed it. That was followed by Bristol Myers Squibb’s Yervoy (ipilimumab), a human cytotoxic T-lymphocyte antigen 4 (CTLA-4) inhibitor, which was prescribed by 77% of oncologists and then Keytruda, prescribed by 75% of respondents.

Zitter Insights and AIS Health are both MMIT companies.

More than one-third of respondents said that Opdivo was their most ideal first-line metastatic melanoma treatment, followed by Keytruda, cited by more than one-fifth of oncologists (see chart). Opdivo also was chosen as the No. 1 second-line therapy, edging out Keytruda and Yervoy.

For more information on the Zitter Insights data, contact Jill Brown Kettler at jbrown@aishealth.com.

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