MARKET NEWS

FDA approval sought for taxol Bristol-Myers Squibb plans to file an

application for FDA approval of taxol. Taxol is used to treat refractory ovarian cancer and has shown promise in the treatment of advanced breast cancer and other tumours [see Inpharma 827: 9, 7 Mar 1992].

The Wall Street Journal reports that Bristol­Myers Squibb are hopeful that an approval could be granted in early 1993.

At present, taxol is obtained from the bark of the rare Pacific yew tree. In 1991, the company delivered 1.35kg of taxol to the National Cancer Institute and plans to deliver 16kg this year. However, in 1993 the company estimates that it will have to, and will be able to, supply 40-50kg to meet research needs and to treat patients with refractory ovarian cancer (estimated to be 12500 women).

Taxol is being collected from bark on private lands and the company is working with the government to obtain raw materials from federal lands while alternative sources of taxol are currently being investigated.

Revenue from taxol sales is expected to reach $US50 million in 1993 and to increase to $350 million in 1995 if approval is granted. 9783

ISSN 0156-2703/92/0314-0021/$1 ,00/0 © Adis International Ltd

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INPHARMAQll 14 Mar 1992