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Executive Summary

BRISTOL-MYERS WILL LAUNCH PARAPLATIN THE WEEK OF MARCH 27 for the treatment of recurrent ovarian cancer following the drug's approval by FDA on March 3. The injectable analog of Bristol-Myers' Platinol (cisplatin) will be available in 50 mg and 150 mg vials in packages of 10, as well as in 450 mg vials in packages of six. Recommended dosage is 360 mg/m on day one every four weeks. According to the approved labeling, Paraplatin "is indicated for the palliative treatment of patients with ovarian carcinoma recurrent after prior chemotherapy, including patients who have been previously treated with cisplatin." The approved indication conforms to the recommendation of FDA's Oncologic Drugs Advisory Committee, which recommended approval as a second line treatment in relapsed patients ("The Pink Sheet" Jan. 2, p. 10.) The labeling adds that in "two randomized controlled studies in patients with advanced ovarian cancer previously treated with chemotherapy, Paraplatin achieved six clinical complete responses in 47 patients." Like cisplatin, carboplatin is licensed from the National Institutes of Health. The newly approved anticancer agent also has been one of the agents cited by the National Cancer Institute in its ongoing dispute with FDA over the approval of new cancer drugs. NCI had argued that the agent should receive expedited approval on the basis of limited data because of a superior safety profile to Platinol. Bristol-Myers submitted its NDA for Paraplatin in June 1988. The drug was reviewed by FDA's Oncologic Drugs Advisory Committee on Dec. 19. At that meeting, the panel said it would be willing to address the question of first-line therapy when additional data became available. The company said it is committed to studying Paraplatin "in all areas where Platinol is useful." Platinol is currently approved in established combination therapy for metastatic testicular and ovarian tumors, and as a single agent in advanced bladder cancer. At the advisory committee meeting, FDA Office of Drug Evaluation I Director Robert Temple, MD, indicated that Bristol-Myers has already begun submission of data to the agency in support of broader use of Paraplatin. Paraplatin is contraindicated in patients "with a history of severe allergic reactions to cisplatin or other platinum compounds," according to the labeling. In addition, the labeling notes that the drug "should not be employed in patients with severe bone marrow depression or significant bleeding." One of the apparent safety advantages of carboplatin over its parent compound is in the area of renal toxicity, the major doselimiting toxicity of cisplatin. Regarding liver toxicity, the labeling points out that the development of "abnormal renal function test results is uncommon, despite the fact that carboplatin, unlike cisplatin, has usually been administered without high-volume fluid hydration and/or forced diuresis." However, the labeling notes that bone marrow suppression "is dose-related and may be severe, resulting in infection and/or bleeding." The labeling also warns of anemia, which "may be cumulative and may require transfusion support."

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