© 2002 by Oxford University Press
Journal of the National Cancer Institute, Vol. 94, No. 22, 1669,
November 20, 2002
© 2002 Oxford University Press
NEWS |
Programs that Provide Access to Unapproved Drugs
Investigational drugs that are in clinical trials but that have not yet been approved by the U.S. Food and Drug Administration can be made available to patients under the following protocols. In each case, the company that manufactures the drug has to decide to embark on the program and provide the drug.• Investigational New Drug (IND) Treatment Program: The FDA has expedited access to drugs under investigation for cancer and other serious diseases since the 1970s. However, no formal regulations were in place until 1987 when the FDA Modernization Act (FDAMA) codified the criteria used for an Investigational New Drug (IND) treatment program. Recently, the three major expanded access programs for cancer drugs involved oxaliplatin (Eloxatine, approved in August for colorectal cancer), gefitinib (Iressa, recommended for accelerated approval in September as third-line therapy for non-small-cell lung cancer), and imatinib (Gleevec, approved in May 2001for chronic myelogenous leukemia).
• Single-Patient Access Treatment Program: This is a type of IND treatment program in which an individual patient can receive an investigational drug. Each request is determined on a case-by-case basis.
• Group C: This is the National Cancer Institute equivalent to an IND treatment program and is administered by the NCI under an agreement with the FDA. Since the mid-1970s, only 20 drugs have been classified as Group C drugs; currently the only Class C drug is 5-azacitidine, a therapy for the treatment of refractory acute myelogenous leukemia (AML). The NCI is also able to make investigational drugs available to individual patients via a special exception protocol, which is equivalent to an emergency IND.
CiteULike 
Connotea 
Del.icio.us What's this?
| ||||||||||||||||||||||||||||||||||||||||||||