TOKYO -- The Health, Labor and Welfare Ministry is set to approve in March the production and sales of a revolutionary new cancer immunotherapy drug, which is designed to strengthen patients' immune cells.
A subcommittee of the ministry's Pharmaceutical Affairs and Food Sanitation Council (PAFSC) has agreed to approve the drug, which will be used for the types of leukemia and lymphocyte tumors that are difficult to cure, at a meeting on Feb. 20. The drug is expected to be the new core for cancer treatment.
Moreover, the PAFSC subcommittee also endorsed a drug for critical limb ischemia, an illness that could lead to amputation. Both drugs use gene therapy technology.
The health minister will give the final OK to the production and sales of these pharmaceutical products, and public health insurance will apply to the drugs beginning as early as this coming summer.
The new immunotherapy drug is called "Kymriah" and is to be sold by Novartis Pharma, the Japanese wing of the Switzerland-based pharmaceutical giant Novartis International AG. The pharmaceutical product is aimed at curing B-cell acute lymphoblastic leukemia and diffuse large B-cell lymphoma.
Kymriah will be used in the so-called CAR T-cell therapy. In that treatment, immune cells, a form of lymphocyte cells, are extracted from patients' bodies and their genes are modified at a Novartis facility in the United States to increase their power to attack cancer cells before being returned to the patients' bodies. The therapy has already been approved in North American and European countries. In the United States, the treatment costs a hefty 52 million yen.
The therapy will be used for patients aged 25 or younger for whom anticancer drugs and other existing treatment methods are ineffective and those whose cancer have recurred. Some 250 patients in Japan are expected to use the therapy per year. In clinical tests, the condition of approximately 80 percent of leukemia patients and about half of lymphocyte cancer sufferers improved after treatment.
Meanwhile, the new drug for critical limb ischemia is Collategene developed by AnGes Inc. based in the western Japan prefecture of Osaka. The pharmaceutical product contains substances with special genes capable of creating new blood vessels and is injected into patients' leg muscles. The mechanism of the genes forming blood vessels was discovered by an Osaka University research team.
Critical limb ischemia is triggered by poor arterial blood flow in the lower limbs as a result of arteriosclerosis, Buerger's disease or other illnesses. The disease causes severe pain, which could lead to amputation. In clinical studies, the conditions of some 70 percent of patients improved. Some 5,000 to 20,000 patients per year are expected to use the drug, according to AnGes.
However, the PAFSC subcommittee has deemed that the effects of the drug have not been confirmed yet and its approval will be limited to five years. The panel demanded that the company conduct a survey comparing patients who use the drug and those who do not.
(Japanese original by Takeshi Noda, Medical Welfare News Department)