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IFOSFAMIDE FOR GERM CELL CARCINOMA IS SECOND TREATMENT IND APPROVED BY FDA

Executive Summary

Bristol-Myers ifosfamide as part of a chemotherapy regimen for germ cell carcinoma is the second product to receive FDA approval for distribution under a Treatment IND. The National Cancer Institute (NCI) received approval from FDA during the week of Dec. 28 for a Treatment IND protocol involving use of ifosfamide with cisplatin and either vinblastine or etoposide. Mesna will also be used in the regimen to prevent the urinary-bladder toxicity associated with ifosfamide. The regimen has been under study by NCl at the University of Indiana. Fifty-eight patients have been studied to date. It is estimated that 900 germ cell carcinoma patients per year in the U.S. will be candidates for the use of the ifosfamide regimen under the Treatment IND. Bristol-Myers has rights to ifosfamide (Naxamide) in the U.S The firm is also developing the drug for soft tissue and bone sarcoma. The German firm Asta-Werke is supplying the drug for distribution under the Treatment IND. The first Treatment IND to be approved by FDA was for use of cytomegalovirus immune globulin in kidney transplant patients. The Treatment IND was granted in October to the Massachusetts Department of Health, which had conducted testing on CMV-1G, for use in Massachusetts hospitals ("The Pink Sheet," Oct. 26, p. 6). Warner-Lambert has been working in conjunction with NCI and the National Institute of Allergy and Infectious Diseases (NIAID) to prepare a Treatment IND for use of trimetrexate in AIDS patients with Pneumocystis carinii pneumonia. It is anticipated that an acceptable protocol will be worked out with FDA within the next few months. Phase III comparative trials of the drug for both primary and second-line treatment for P. pneumonia in AIDS patients are currently being set up. Other cancer drugs also being considered by NCI as possible candidates for Treatment INDs include Bristol-Myers' teniposide, for acute lymphocytic leukemia (refractory) and Parke-Davis' pentostatin, to treat hairy cell leukemia (refractory to alpha interferon). At a recent FDA advisory committee meeting, FDA oncologic division staffer John Johnson, MD summarized FDA's progress to date with Treatment INDs. Johnson noted that the agency has received seven treatment protocols, including two for cancer drugs. One of the two, ifosfamide, was approved, and the other rejected. Four of five treatment protocols for non-cancer drugs were denied, Johnson said.
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