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LEDERLE's NOVANTRONE APPROVED FOR ADULT ACUTE NONLYMPHOCYTIC LEUKEMIA DEC. 23. TWO WEEKS AFTER ADVISORY PANEL: NEW INDICATION REVIEWED IN UNDER A YEAR

Executive Summary

Lederle's Novantrone (mitoxantrone) NDA for acute nonlymphocytic leukemia (ANLL) in adults was approved on Dec. 23, only two weeks after FDA's Oncologic Drugs Advisory Committee reviewed the drug. At its Dec. 7 meeting, the committee had voted seven to one in favor of recommending approval of Novantrone for the leukemia indication ("The Pink Sheet" Dec. 14, p. 11). According to approved labeling, "Novantrone in combination with other approved drug(s) is indicated in the initial therapy of acute nonlymphocytic leukemia in adults. This category includes myelogenous, promyelocytic, monocytic, and erythroid acute leukemias." The approved indication reflects the advisory committee's recommendation against approving the drug for refractory ANLL patients. Lederle was seeking approval for both refractory and initial ANLL patients; however, the committee felt that not enough data was submitted to support the refractory indication. Lederle said it plans to lauch Novantrone "in early 1988." Novantrone is currently marketed in 35 other countries for breast cancer and ANLL. Lederle submitted the ANLL NDA this year; the initial NDA for breast cancer was filed in 1984. In addition to FDA's traditional late December approval rush, the short time frame between the advisory committee review and approval may reflect pressures on the agency to clear the drug for marketing. FDA has been criticized by the National Cancer Institute (NCI) for holding up approval of Novantrone for breast cancer ("The Pink Sheet" Oct. 5, T&G-5). At an NCI meeting in October, FDA Office of Drug Evaluation and Research I Director Robert Temple, MD, pointed out that although FDA had not accepted the advisory committee's March 1986 recommendation to approve the drug for breast cancer, the ANLL data, which was to be reviewed for the first time by the advisory committee at its December meeting, looked promising. The breast cancer data has been somewhat more controversial. At the Dec. 7 meeting, the advisory committee, after reviewing the data for the third time, reversed its prior approval recommendation. Lederle's ANLL NDA was based on trials comparing the combination of Novantrone and cytosine arabinoside (also known as cytarabine) to daunorubicin (Wyeth's Cerubidine) and cytosine arabinoside. Efficacy data included in the labeling reports that in the U.S. trial 63% of Novantrone-treated patients had complete response compared to 53% of daunorubicin-treated patients. The median time to remission was 35 days with Novantrone compared to 42 days with daunorubicin, while median survival was 312 days with Novantrone and 237 days with daunorubicin. Novantrone is the first new cytotoxic agent to be approved for the treatment of cancer since 1983 when Bristol-Myers' Vepesid (etoposide) was approved. Novantrone labeling notes in the "Warnings" section that "when Novantrone is used in doses indicated for the treatment of leukemia, severe myelosuppression will occur." Labeling adds: "Laboratory and supportive services must be available for hematologic and chemistry monitoring and adjunctive thereapies, including antibiotics . . . Particular care should be given to assuring full hematologic recovery before undertaking consolidation therapy (if this treatment is used) and patients should be monitored closely during this phase." At the December advisory committee, FDA indicated that Novantrone labeling should reflect myelosuppressive effects of the drug. During the consolidation phase of the foreign trial, there were eight deaths in the Novantrone group, compared to zero in the daunorubicin group, that were throught to be related poor antibiotic care of myelosuppressed patients.
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