J&J committed to Zarnestra despite "not approvable" letter
This article was originally published in Pharmaceutical Approvals Monthly
Johnson & Johnson says it remains committed to developing Zarnestra (tipifarnib) despite a "not approvable" letter for the oral leukemia agent based on Phase II trials. The letter, announced June 30, requests additional information about study patients, J&J says. The firm is seeking an indication for acute myeloid leukemia in elderly patients who are not candidates for standard chemotherapy; a Phase III study is ongoing...
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