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March 15th, 1999
"Vinorelbine Tartrate"
NDA approval of A New Anticanser Drug

  The Japanese Ministry of Health and Welfare approved the NDA for "Vinorelbine tartrate", a therapeutic agent of non-small cell lung cancer, filed by our Kyowa Hakko Kogyo Co., Ltd. (President: Dr. Tadashi Hirata), as of the 12th March, 1999.
  "Vinorelbine tartrate" is an anticancer drug of the vinca alkaloid class introduced from Pierre Fabre Medicament in France. It was originally extracted from periwinkle as a plant alkaloid exhibiting a potent antitumor activity. It is now produced by chemical synthesis. Anticancer action of this compound is thought to be due to inhibition of mitosis at metaphase of cancer cells.
  We have developed this compound as a therapeutic agent of non-small cell lung cancer. In clinical study, a very excellent response rate (an indicator of cancer reducing effect) was obtained by the triple drug regimen with a platinum preparation and mitomycin. Survival prolongation was also demonstrated in combination of this agent and a platinum preparation. This compound was also demonstrated to cause less peripheral nerve damages (paralysis of the extremities, etc.), which is a side effect peculiar to vinca alkaloids and causes an important problem in clinical use, and will improve the QOL of the patients.
  This compound has been already launched in more than 70 countries of the world as a therapeutic agent of non-small cell lung cancer and breast cancer. We are going to add the indication of breast cancer in near future.
  Kyowa Hakko is engaged in research and development of pharmaceutical products in cancer field since the 1950s and we have now 14 products in 8 categories including the introduced products from abroad. Absolute cancer therapy is still unavailable despite of recent drastic progress in recent cancer treatment and various combinations of treatments are tried. We are also going to advance the research activities positively to make an important contribution in cancer field.


Clinical dose of vinorelbine tartrate 25 to 30mg/m2
Preparation Navelbine Injection 10 containing 13.85mg as vinorelbine tartrate
Navelbine Injection 40 containing 55.40mg as vinorelbine tartrate


<Outline of Pierre Fabre Medicament>
Representative: Dr. Pierre Fabre
Address: 45, Place Abel-Grance, 92654 BOULOGNE CEDEX, France
Sales amount: 6,000 million FF
Activity: One division of Pierre Fabre (France) in charge of pharmaceutical products



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