BETHESDA -- Bristol-Myers Squibb Co. won the support of government medical experts yesterday to expand the approved uses of its $900 million Taxol cancer drug to include advanced, usually fatal, forms of lung and ovarian cancer.
A Food and Drug Administration advisory panel recommended use of the drug for lung cancer patients who cannot be cured by radiation or surgery and as a primary weapon in the treatment of advanced ovarian cancer.
Panel members said they were impressed by studies for both new uses that show adding the drug into treatment regimens could extend the lives of patients suffering from the usually terminal advanced forms of the diseases.
But they cautioned that it provided only a small benefit over typical treatment, extending by about two months the lives of patients who were not candidates for radiation or surgery but who were given Taxol in combination with cisplatin, another cancer drug.
About 178,000 Americans will be diagnosed with lung cancer this year. Five-year survival is just 13 percent.
Shares in New York-based Bristol-Myers rose $1.6875, to $108.625 yesterday.
Currently, Taxol is approved for treating advanced ovarian cancer only when other treatments don't work. It's also approved for treating breast cancer, and AIDS related Kaposi's sarcoma.
As one of the most prescribed cancer drugs, with worldwide sales of $941 million in 1997, Taxol is widely used for unapproved, or "off-label" purposes. Company officials say it's already used in 80 percent of advanced ovarian cancers and paid for by many insurance companies, so they don't expect large sales gains if the FDA gives its formal blessing to that use.
Still, having the FDA's stamp allows the company to promote the additional approved uses, and makes it easier for patients to get their treatments reimbursed, analysts said.
Late Thursday, the advisory panel also recommended FDA approval of Roche Holding AG's Xeloda, a drug that offers a gentler form of treatment for breast cancer patients weakened by chemotherapy, for women in whom other treatments have failed.
Panel members said it was difficult to determine the absolute benefit of Xeloda, but said women with advanced breast cancer have very few options.
The advisory committee recommended "accelerated" approval, which means it believes that the drug benefits patients, but requires Roche to continue tests to confirm that benefit after the drug is on the market.
Pub Date: 3/21/98