FDA Clears Semisynthetic Taxol

January 1, 1995

ROCKVILLE, Md--The Food and Drug Administration has approved a semisynthetic source of Bristol-Myers Squibb Company's anticancer agent Taxol (paclitaxel), produced from renewable Taxus baccata plant sources.

ROCKVILLE, Md--The Food and Drug Administration has approved asemisynthetic source of Bristol-Myers Squibb Company's anticanceragent Taxol (paclitaxel), produced from renewable Taxus baccataplant sources.

Previously, the only source of pac-litaxel approved for humanuse was the bark of the Pacific yew, an endangered tree foundin the Northwest region of the United States. The use of renewablesources completely eliminates the need for Pacific yew bark harvestingand ensures the continuous availability of the agent for patientswith metastatic ovarian or breast cancer.

In clearing semisynthetic paclitaxel, the FDA determined thatit is bioequivalent to that produced from yew bark. The productionprocess involves extraction of a precursor to paclitaxel fromTaxus baccata sources, such as needles and twigs, which is thensynthesized to the active ingredient, paclitaxel, and formulatedinto finished Taxol.