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Executive Summary

ADRIA LABS' IDAMYCIN (IDARUBICIN) APPROVED SEPT. 27 for combination therapy in acute myeloid leukemia, less than three weeks after the Company's presentation of final study results at FDA's Oncologic Drugs Advisory Committee meeting ("The Pink Sheet" Sept. 17, p. 6). Draft labeling states that "Idamycin in combination with other approved antileukemic drugs is indicated for the treatment of acute myeloid leukemia (AML) in adults." FDA gave the drug a "1A" rating (offering an important therapeutic gain over existing therapies). Adria filed the NDA in August 1989; Idamycin was classified as an orphan drug in July 1988. Adria expects to launch Idamycin "near the end of the year." The company has not announced marketing plans for the drug. Sister company Farmitalia Carlo Erba, based in Milan, Italy, will manufacture the product. An Oct. 5 release from Erbamont, Adria's parent company, says that "the cost of therapy with Idamycin will be approximately 4% of the total cost of treating the disease, which averages about$30,000." On that basis, Idamycin therapy would cost roughly$1,200. The standard treatment for acute myeloid leukemia is a combination of daunorubicin and cytarabine. The labeling states that the clinical data "demonstrate significantly greater complete remission rates for the IDR regimen (idarubicin in combination with cytarabine) in two of the three U.S. studies and significantly longer overall survival for the IDR regimen in two of the three U.S. studies." The recommended dosage of idamycin is 12 mg/m daily for 3 days by slow intravenous injection in combination with Ara-C, either 100 mg/m daily given by continuous infusion for seven days or as a 25 mg/m IV bolus followed by 200 mg/m daily for 5 days by continuous infusion. FDA's approval letter includes two recommendations for post-marketing studies: "Because of the long plasma half-life of both parent and metabolite and the known toxicity of the anthracycline antibiotics, the use of idarubicin in patients with renal and/or hepatic insufficiency should be studied"; and "because of the relatively small portion of the total dose accounted for after administration, we recommend investigation of the metabolic fate of idarubicin and idarubicinol." The labeling states that toxicities and duration of aplasia "were similar during induction" in the idarubicin and daunorubicin arms of the U.S. studies, except for a higher incidence in mucositis on the idarubicin arm of one study. Duration of aplasia on the idarubicin arm was longer in all three studies during consolidation; mucositis was more frequent on the idarubicin arm in two of the studies at the consolidation phase. "Severe myelosuppression is the major toxicity associated with Idamycin therapy," labeling states; it adds that patients in the myelosuppression period "are at risk of developing infection and bleeding which may be life-threatening or fatal." Long-term carcinogenicity studies with the drug have not been conducted, but "Idamycin and related compounds have been shown to have mutagenic and carcinogenic properties when tested in experimental models," labeling notes. The three U.S. trials involved a total of 574 acute myeloid leukemia patients. An estimated 550 patients have received Idamycin in controlled studies worldwide, with an additional 550 or more having received the drug alone or in combination in uncontrolled trials.

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