FDA Approves Taxol for Use in AIDS-Related KS

ROCKVILLE, Md—The Food and Drug Administration (FDA) has cleared Bristol-Myers Squibb’s Taxol (paclitaxel) Injection for use in the second-line treatment of AIDS-related Kaposi’s sarcoma (KS). Taxol is also approved for second-line use in metastatic breast and ovarian cancer.

In 1993, Bristol-Myers Squibb researchers, working in collaboration with scientists from the National Cancer Institute, discovered that the agent has activity against Kaposi’s sarcoma. This led the company to sponsor independent clinical trials of the agent in patients with AIDS-related KS.

In these studies, involving KS patients who had failed previous therapy, a majority of those treated with Taxol benefited from the therapy. Treatment with Taxol resulted in shrinkage of tumors and relief of symptom, including less edema and pain, and general improvement in the patients’ performance status.

The most common side effect of Taxol in these studies was myelosuppression; other side effects included alopecia and muscle soreness.