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Opdivo approved for use in gastric cancer

  • September 9, 2017
  • , Mainichi , p. 28
  • JMH Translation

On Sept. 8, a subcommittee of the Pharmaceutical Affairs and Food Sanitation Council (PAFSC) of the Ministry of Health, Labor and Welfare (MHLW) approved the use of Opdivo (generic name: Nivolumab) to treat gastric cancer. The new application will be formally approved at the end of this month and will be covered by insurance. Opdivo is known as the super-expensive cancer drug.


Japan has about 132,000 new cases of gastric cancer every year, making it the second most frequent type of cancer. The only patients who will be able to be treated with Opdivo, however, are those whose condition has deteriorated to the state where two other types of chemotherapy have been unsuccessful and tumor excision is not possible. Ono Pharmaceutical Co., Ltd. (Osaka City), the producer and marketer of the drug, anticipates about 4,600 patients will use the drug every year.


Opdivo was marketed in 2014 as a drug for certain rare types of skin cancer. Its range of use was later expanded to include lung cancer, and about 10,000 patients are treated with it per year. Last December, the company submitted an application to broaden the application of Opdivo to gastric cancer, and the Pharmaceuticals and Medical Devices Agency (PMDA) screened it for efficacy and safety. The MHLW estimates that treatment will cost about 39,000 yen a day.


The cost of Opdivo treatment per patient is estimated at 35 million yen per year, and concerns have been raised about Opdivo’s impact on national medical expenses. The MHLW halved the price of the drug in February this year.


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