Ono Pharma Korea and Bristol-Myers Squibb (BMS) Korea said Thursday its blockbuster immunotherapy Opdivo gained approval for seven indications for six cancer types, recording the highest number of indications among domestic immunotherapies.
The Ministry of Food and Drug Safety recently approved Opdivo to treat renal cell carcinoma, bladder cancer, head and neck cancer, and Hodgkin lymphoma and expanded indications for a Yervoy-Opdivo combination treatment to treat melanoma.
Gaining seven indications for one drug comes as a historic first for anti-cancer drugs in Korea, the company said.
“Getting indications for five cancer types that have little treatment alternatives at one time is unprecedented,” said BMS Korea한국BMS CEO Park Hye-sun박혜선. “As a leader in the field of immuno-oncology, we will do our best for patients who need more treatment options by committing more to research and development.”
Multiple CheckMate clinical trials proved the safety and efficacy of the drug for each indication, the company said.
Ono Pharma Korea and BMS will continue to support the promotion of license-out products, Ono said. The two companies signed a strategic collaboration agreement to jointly develop and commercialize immunotherapies in Japan, Korea and Taiwan in 2014.
“Opdivo has expanded its indications in Korea following Japan, U.S. and Europe, having proved its clinical efficacy in various cancer types. We believe the recent expansion of indications to be significant as it allows cancer patients who had limited treatment options to access our innovative immunotherapy Opdivo,” said Ono Pharma Korea CEO Kunihiko Ito.
Ono also plans to commercialize specialty products such as immunotherapies such as Opdivo, the company said.
The ministry has also allowed insurance coverage for the immunotherapy to treat non-small cell lung cancer along with Merck & Co’s Keytruda on Aug. 21.
The government set the price of Opdivo at 1.3 million won per 100mg, or 331,700 won per 20mg. Keytruda has been set at 2.8 million won ($2,461) per 100mg.
“We are delighted to tell our patients that the indications for Opdivo have been expanded following the insurance listing of the drug. Considering the indications approved for this study includes cancers with poor prognosis, the expanded indications for the drug will not only open new chapter for cancer treatment but also lead to a positive change in how patients decide on the direction of their treatment,” said Professor Ahn Myung-joo안명주 at Samsung Medical Center삼성서울병원.
In the United States and Europe, Opdivo is currently used to treat for non-small cell lung cancer, melanoma, renal cell carcinoma, typical Hodgkin's lymphoma, head and neck cancer, and urothelial carcinoma. The U.S. FDA also approved the drug to treat dMMR or MSI-H colon cancer early this month.
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