TRIMETREXATE TREATMENT IND FOR P. CARINII PNEUMONIA ANTICIPATED

Executive Summary

TRIMETREXATE TREATMENT IND FOR P. CARINII PNEUMONIA ANTICIPATED by the National Cancer Institute. NCI's Cancer Therapy Evaluation Program lists trimetrexate among five agents for which the institute plans to seek Treatment IND status in the institute's recently-released "1987 Report of the Division of Cancer Treatment." Trimetrexate "has shown substantial activity in AIDS patients with Pneumocystic carinii pneumonia, both as initial therapy and in patients either resistant or intolerant to trimethoprim/sulfamethoxate and pentamidine," the NCI report notes. The institute reports that a randomized Phase III trial is about to begin. Furthermore, "as an anticancer agent, trimetrexate has so far shown 20% activity in non-small cell lung cancer and 16% activity in head and neck cancer," the report notes. Warner-Lambert is the sponsor for trimetrexate. NCI is interested in the Treatment IND for trimetrexate because it might be a simpler administrative process than the Group C route for obtaining approval. Presumably, Warner-Lambert will have to apply for the Treatment IND. The other potential Treatment IND drugs being pushed by NCI are Bristol-Myers' teniposide, for acute lymphocytic leukemia (refractory), and the anti-cancer agent ifosfamide (Naxamide); Parke-Davis' pentostatin, to treat hairy cell leukemia (refractory to Interferonalpha); and Lederle's mitoxantrone (Novantrone) for advanced breast cancer. FDA apparently is not ready to approve a mitoxantrone NDA. Ifosfamide has shown "significant activity in adult soft-tissue sarcoma, pediatric sarcomas, and refractory testicular carcinoma," NCI said. A total of 15 INDs, seven drugs and eight biologics, were submitted by the NCI's Regulatory Affairs Branch to FDA in fiscal 1987 (ended Sept. 30). Twelve INDs were discontinued during that time. Ten of the agents were drugs; two were biologics. Chart omitted.