FDA Accepts Merck’s Supplemental Application for Keytruda in Advanced Melanoma


The U.S. Food and Drug Administration (FDA) accepted Merck’s new supplemental Biologics License Application (sBLA) for Keytruda as adjuvant therapy in patients with resected, high-risk stage III melanoma. The target action date is February 16, 2019.

The application was built on data from Merck’s pivotal Phase III EORTC1325/KEYNOTE-054 clinical trial, which was conducted in collaboration with the European Organization for Research and Treatment of Cancer (EORTC). The data were presented at the American Association for Cancer Research (AACR) Annual Meeting 2018, and published in The New England Journal of Medicine.

“EORTC1325/KEYNOTE-054 was the first trial with Keytruda to demonstrate a recurrence-free survival benefit in the adjuvant setting, and we continue to actively investigate Keytruda in the adjuvant or neoadjuvant setting across our broad clinical development program,” said Scot Ebbinghau, vice president, clinical research, Merck Research Laboratories, in a statement. “Earlier intervention with adjuvant therapy has proven to be an important factor in reducing the risk of recurrence following surgery for patients with high-risk stage III melanoma. We look forward to working with the FDA on the review of this application, with the goal of bringing Keytruda to patients with advanced melanoma earlier in their treatment.”

Keytruda is an anti-PD-1 immuno-therapeutic, and for Merck, has been the drug that keeps on giving. The FDA had a decision date for Merck’s supplemental Biologics License Application (sBLA) for Keytruda for treatment for patients with advanced cervical cancer with disease progression on or after chemotherapy of June 28. It was the first filing and Priority Review granted for the anti-PD-1 therapy in cervical cancer and the 14th regulatory submission accepted by the FDA for Keytruda. But the agency got to it on June 12, approving it for the indication. “Keytruda is now the first anti-PD-1 therapy approved for the treatment of advanced cervical cancer, providing an important new second-line option for certain patients with this disease,” said Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, in a statement.

Keytruda has been approved for use in treating melanoma, lung cancer, head and neck cancer, classical Hodgkin Lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, microsatellite instability-high (MSI-H) cancer, gastric cancer, and cervical cancer.

The drug is being evaluated alone and in combination with other drugs. Its program is made up of more than 4,500 patients across 10 clinical trials.

Melanoma is the most serious type of skin cancer. About 232,000 new cases were diagnosed worldwide in 2012. In the U.S., it is the most common type of cancer and responsible for most skin cancer deaths. In 2018, 91,270 people are expected to be diagnosed, with an estimated 9,320 people expected to die from the disease in the U.S. alone.

Although a miracle drug of sorts, it’s not perfect. In May, the FDA placed restrictions on Merck, as well as Roche for its own PD-1 inhibitor Tecentriq, for the treatment of patients with advanced or metastatic bladder cancer who aren’t eligible for cistplatin-containing chemotherapy. Keytruda is only approved for patients whose tumors express specific levels of PD-L1 that meet a combined positive score of 10 or higher. Tecentriq is only approved for patients whose PD-L1 immune cells cover five percent or more of their tumor area.

The FDA did, however, say both drugs can be used regardless of PD-L1 status if the patients aren’t eligible for any platinum-containing therapy.

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