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ADRIA COMPILING ADRIAMYCIN EFFICACY SUPPLEMENT

Executive Summary

ADRIA COMPILING ADRIAMYCIN EFFICACY SUPPLEMENT for islet cell carcinoma in response to a recent request by FDA. Islet cell carcinoma, a cancer of the pancreas, occurs in 500 to 2,000 individuals annually, Adria said. Adriamycin (doxorubicin) is indicated for treating numerous cancers. Adria is one of a number of companies that FDA has asked to submit NDA supplements for off-label uses of their approved cancer drugs. FDA Commissioner Kessler announced in January 1992 that the agency was taking a proactive role in encouraging the filing of supplements for such products. At the time, he noted that FDA already had approached two unnamed oncology companies about submitting supplemental applications ("The Pink Sheet" Feb. 3, 1992, p. 8). Following Kessler's remarks, but without further prompting from FDA, Lederle began developing literature-based supplements for Novantrone (mitoxantrone) in treating relapsed leukemia and breast cancer patients ("The Pink Sheet" Oct. 12, 1992, T&G-7). The company said Jan. 7 that it has not yet submitted the supplements and that it has no time frame for so doing. FDA plans to send out letters to manufacturers and medical specialty societies requesting them to identify off-label uses of products and information in the literature on those uses. That letter could go out in January. An article written by Kessler on the subject is expected to be published soon in the Journal of the American Medical Association. Kessler said in January 1992 that some supplements could be approved on the basis of medical literature on off-label uses. Adria submitted a citizen's petition to FDA on Dec. 14 requesting that "FDA issue written procedures defining the circumstances under which a manufacturer may submit an efficacy supplement for a cancer or AIDS drug consisting primarily of data and information appearing in published literature." After checking its internal database and conducting a search of the literature on the use of Adriamycin in islet cell carcinoma, Adria said it came to realize that it had no FDA guidelines to follow on what information should be submitted in the efficacy supplement. Adria's petition states that a "procedure is needed to assure that the standards for approval are not lowered and the process is clearly understood." This "procedure should be published for comment in the Federal Register prior to being finalized," Adria said. The issues that FDA should address include "whether the published data and information must be contained in a reputable peer-reviewed publication, the number of studies required for approval [and] the supporting data/information which must be submitted in addition to that contained in the published literature." The company suggested that the procedure for filing supplements include certain requirements. "Normally, at least two adequate and well-controlled studies [from the literature] should be required to support an application based on the published literature," Adria said. "The applicant should have the burden of showing that the studies meet the requirements of [the section of the Code of Federal Regulations that defines adequate studies] and in cases where some of these requirements are not met, establishing why they are irrelevant to an approval decision." Adria also recommended that "each publication should be accompanied by the protocol of study, the sponsor summary, appropriate statistical analyses, safety data, and a discussion of benefit/risk." Also, if necessary, the sponsor "should be able to provide the FDA with raw data and case report forms and assurance that [institutional review board] and informed consent requirements were followed." Adria said the criteria that it wants addressed by FDA are the type of information the company routinely submits in its supplemental applications and is information that FDA normally requires.
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