MSD Korea said Tuesday that it got expanded coverage for Keytruda (pembrolizumab) as a first-and later-line therapy to treat melanoma from the Ministry of Drug and Food Safety early this month.

Keytruda

Melanoma patients who did not receive anti-PD-1 or PD-L1 immunotherapies and cannot undergo surgery or melanoma patients whose tumor has metastasized can now benefit from the expanded coverage of Keytruda as a first-and later-line therapy.

The patient will pay around 142,300 won ($133) per vial as government policies allow cancer patients to pay only 5 percent of the maximum drug cost, the company said.

Keytruda is administered intravenously once every three weeks for 30 minutes in 2mg/kg doses. The therapy is stopped if the patient’s disease progresses or if the patient reaches a level of unacceptable toxicity.

"We have been providing effective and economical treatment options for some non-small cell lung cancer patients in Korea based on various clinical studies and proven efficacy in the actual field,” said MSD Korea CEO Avi Benshoshan. “We are very pleased to be able to reduce the financial burden on melanoma patients and provide the clinical benefits of Keytruda.”

Melanoma is a skin cancer that develops in the pigment cells in the skin called melanocytes. The disease may be more severe than other cancers because it may spread to other parts of the body. Melanoma accounts for around 65 percent of all skin cancer deaths, according to MSD Korea.

The Korean approval is based on results from the KEYNOTE-006 study that pitted Keytruda against Yervoy (ipilimumab). The study aimed to find the overall survival of 834 melanoma patients that could not undergo surgery or whose cancer spread to other parts of the body. Findings showed the two-year survival rate to be 55 percent in patients who took Keytruda every three weeks and 43 percent in those who received Yervoy every three weeks.

The company is conducting about 600 Keytruda clinical trials for some 30 carcinomas and the drug recently gained expanded indications for head and neck cancer, Hodgkin’s lymphoma, and certain types of bladder cancer in Korea. It is the only immunotherapy approved to treat NSCLC patients as first and second-line therapy alone or as a combination therapy in Korea, the company said.

yjc@docdocdoc.co.kr

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