FDA Urged to OK Drug for Ovarian Cancer : Health: The agency’s oncologic committee recommends approval of taxol after studies show it to be effective.

Encouraged by studies demonstrating the effectiveness of the experimental anti-cancer drug taxol, a federal advisory committee Monday recommended that the Food and Drug Administration approve its use for the treatment of advanced ovarian cancer.

Studies have shown that the drug--once in short supply because its sole source was the bark of the Pacific yew tree--can shrink tumors by at least 50% in up to nearly one-third of those women whose cancer has been unresponsive to other therapies. Results have also shown taxol could be effective against other cancers, including breast cancer, lung cancer and melanoma, say researchers who have studied the drug.

Under the recommendation taxol would be permitted for use in patients who failed to respond to at least one round of chemotherapy.

A recommendation from the agency’s oncologic drugs advisory committee, a panel of outside experts, likely means the FDA will license the drug for marketing. While not bound by its committees’ recommendations, the agency almost always heeds their advice.

The Pacific yew tree is found primarily in old-growth forests protected by environmental restrictions. More than 60 pounds of bark from the slow-growing yew are needed to develop enough taxol to treat one patient for a year.

Now, however, officials of Bristol-Myers Squibb Co., the developers of taxol, have contracted with an Italian firm to derive the drug from needles and twigs of more plentiful yew species in Europe and Asia. No one has yet been able to develop a synthetic version.

Dr. Sam Broder, director of the National Cancer Institute, who has been studying the drug for several years, said, “It’s not a cure, but it clearly will make a difference in women’s lives.”

Ovarian cancer, a rare but often deadly disease, is diagnosed in 21,000 women each year in the United States and claims 13,000 lives. Officials estimate that one of every 70 women will develop ovarian cancer.

Often considered a “silent” disease, the cancer shows no obvious symptoms until late in its development. The most common is enlargement of the abdomen, caused by fluid accumulation.

Risk for ovarian cancer increases with age, the institute said. The highest rates are for women over 60. Women who have never had children are twice as likely to develop ovarian cancer as those who have. And women who have had breast cancer are also twice as likely to develop it, physicians said.

Specialists have found that although most patients with the disease initially respond to chemotherapy, the cancer often recurs within a few years.

Broder said that “we made some progress against (the disease) in the 1970s but then leveled off. Now there is no question that this (drug) is a real substantial measure of progress.”

The FDA, responding to urgings from the institute, already had reclassified taxol as a Group C drug, permitting Medicare reimbursement for its use in women whose ovarian cancer has not responded to conventional therapy.

Although private health insurers are not required to follow Medicare’s lead, many will likely do so.

Because taxol is still considered experimental, oncologists can apply to the cancer institute to receive supplies of it and a plan for administering it. This expanded access reflects increased supplies of taxol, indications in ongoing clinical trials of its effectiveness and improved understanding of how to manage its side effects.

Times staff writer Marlene Cimons contributed to this story.