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
Previously, the only source of pac-litaxel approved for human
use was the bark of the Pacific yew, an endangered tree found
in the Northwest region of the United States. The use of renewable
sources completely eliminates the need for Pacific yew bark harvesting
and ensures the continuous availability of the agent for patients
with metastatic ovarian or breast cancer.
In clearing semisynthetic paclitaxel, the FDA determined that
it is bioequivalent to that produced from yew bark. The production
process involves extraction of a precursor to paclitaxel from
Taxus baccata sources, such as needles and twigs, which is then
synthesized to the active ingredient, paclitaxel, and formulated
into finished Taxol.