FDA Advisory Committee to Review New Cancer Treatments

A panel of expert advisors at the U.S. Food and Drug Administration (FDA) is set to review several new cancer treatments, including a possible new use for Taxol, a leading cancer drug that generated $1.2 billion in sales for Bristol-Myers Squibb Co. in 1998. The committee will consider whether Taxol is safe and effective for patients with breast cancer that has spread to the lymph nodes but not throughout the body. Additionally, the panel will review Orzel, a product that combines two drugs to fight metastatic colorectal cancer, and Evacet, a biotechnology firm's treatment for metastatic breast cancer with less severe side effects than doxorubicin.

Key Takeaways:

• The U.S. FDA advisory committee will review Taxol for a new indication in breast cancer patients with lymph node involvement but not widespread disease.
• Taxol, which generated $1.2 billion in sales for Bristol-Myers Squibb Co. in 1998, is already approved to treat ovarian, lung, and breast cancers.
• The committee will consider Orzel, a product combining UFT and leucovorin calcium tablets to fight metastatic colorectal cancer, which, if approved, would be the first oral chemotherapy agent for colorectal cancer.
• Evacet, designed to fight metastatic breast cancer with less severe side effects than doxorubicin, consists of doxorubicin wrapped in a protective capsule to reduce harm to the heart.
• Roferon-A, a Hoffmann-LaRoche Inc. drug, is scheduled to be reviewed for a new indication in treating malignant melanoma, a dangerous skin cancer.
• The committee will also review data from a study of over 3,000 women on Taxol's effectiveness in treating breast cancer.

Statistics:

• $1.2 billion: The sales generation of Taxol for Bristol-Myers Squibb Co. in 1998.
• 3,000: The number of women involved in a study to evaluate Taxol's effectiveness in treating breast cancer.
• 13 years: The time period during which Roferon-A has been sold in the United States.

Sources:

• U.S. Food and Drug Administration (FDA)
• Bristol-Myers Squibb Co.
• Liposome Co. Inc.
• Hoffmann-LaRoche Inc.