IMMUNEX GM-CSF TREATMENT IND APPROVED

IMMUNEX GM-CSF TREATMENT IND APPROVED on Sept. 24 for use in patients experiencing bone marrow transplant engraftment failure or delay. Immunex said it will provide its yeast-derived granulocyte macrophage colony stimulating factor at no cost. FDA estimates that 10%-20% (300 to 600) of the approximately 3,000 bone marrow transplant patients per year have engraftment failure and would benefit from GM-CSF. The Treatment IND review took nearly three months at FDA. Immunex filed its Treatment IND application on July 23, eight days before the company's GM-CSF was considered by FDA's Biological Response Modifiers Advisory Committee on July 31. While the panel recommended the product for a Treatment IND, it also concluded that there were insufficient data to recommend approval of the product's PLA, which was filed in February ("The Pink Sheet" Aug. 6, p. 8). The advisory committee reviewed Immunex data on more than 100 patients at 25 clinical trial sites. Most of the patients treated with GM-CSF responded with higher infection-fighting cell (neutrophil) rates within two weeks of treatment. Survival rates among patients treated with GM-CSF were higher than for "historical controls" -- those who, prior to the development of GM-CSF, received only supportive therapy. The committee concluded that the data and analysis of the historical controls were not sufficient, but did not request an additional study. Instead, the committee said it would rereview the data "as quickly as possible." Immunex said it is responding to the panel's request for data on additional patients treated since the filing. FDA's Biological Response Modifiers Advisory Committee is scheduled to meet once more before the end of the year, on Dec. 13-14. FDA is saying that an agenda for that meeting has not yet been set. However, one or all of the colony stimulating factors now at FDA -- the Immunex product, Schering-Plough/Sandoz' GM-CSF and Amgen's G-CSF -- are possible subjects for committee review. Schering and co-marketer Sandoz filed a PLA in January for Leucomax (licensed from Genetics Institute) for the correction of neutropenia. A PLA for Amgen's Neupogen G-CSF product has been pending at the agency since December 1989 for chemotherapy-associated neutropenia. In its PLA filing, Immunex also sought the broader indication of expediting engraftment in bone marrow transplant patients, for which the patient population is estimated at around 10,000. That portion of the PLA is still under regular FDA review. Immunex plans to market GM-CSF under the tradename Leukine ("The Pink Sheet" Feb. 26, T&G-3). Comarketing partner Hoechst-Roussel will market its own brand of GM-CSF as Prokine.

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