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JNCI Journal of the National Cancer Institute 2002 94(5):325; doi:10.1093/jnci/94.5.325
© 2002 by Oxford University Press
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Journal of the National Cancer Institute, Vol. 94, No. 5, 325, March 6, 2002
© 2002 Oxford University Press

NEWS

Milestones in the Development of Paclitaxel

1958: The National Cancer Institute initiates a program to screen 35,000 plant species for anticancer activity.

1963: The U.S. Forest Service collects Pacific yew tree bark and ships it to the NCI for study. An extract of the bark is found to have antitumor activity.

1971: Paclitaxel, the active ingredient in Pacific yew tree bark, is identified. Development is later suspended because experimental models do not show superior activity and there are problems with producing, extracting, and processing paclitaxel.



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  		The paclitaxel molecule is derived from the bark of the Pacific yew tree.

 
1979: Paclitaxel’s unique mechanism of action—tubulin stabilization—is identified.

1983: The NCI sponsors phase I clinical trials of paclitaxel against numerous cancers. However, allergic reactions, attributed to the solvent in the formula, cause some trials to be discontinued and others to be delayed.

1985: The NCI begins phase II trials of paclitaxel.

1989: Researchers report a 30% response rate in patients with advanced ovarian carcinoma who receive paclitaxel. Supply shortages still hinder drug development.

1991: Bristol-Myers Squibb Company signs a cooperative agreement with the NCI to be a commercial partner in developing Taxol (paclitaxel).

1992: Bristol-Myers Squibb Company obtained an initial FDA marketing clearance, and began producing and distributing the drug.

1993: Pacific yew bark harvesting for the manufacture of Taxol ends and researchers begin to develop other renewable sources for the drug.

1995: The semisynthetic form of paclitaxel, manufactured from renewable sources, receives clearance for marketing from the FDA.

NOTES

Source: Bristol-Myers Squibb


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This Article
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