The FDA approves chemotherapeutic drugs for one or more specific kinds of cancer. For example, taxol was first approved only for treating ovarian cancers that resist cisplatin or carboplatin . In time, however, drugs tend to be used to treat patients with other types of cancer. The FDA does not restrict the use of a drug for non-approved situations. Many such uses, based on literature reports or the personal experiences of oncologists, have become common and appropriate practice.
When a drug is first released, insurance companies in particular tend to regard non-approved uses as "experimental." But distinctions between "established" and "investigational" or"experimental" uses are often blurred. Drugs under investigation have often become therapeutic alternatives for patients who have failed standard treatments or have cancers with no known life-prolonging therapies.
Patients with metastatic breast or ovarian cancers, for example, will have failed standard combination chemotherapy programs before being treated with an investigational drug. An investigational treatment may appropriately be considered by someone with metastatic cancer whose primary site cannot be determined because, in such a case, no "tailor-made" drug therapy has been found to be superior.
