FDA approves Marqibo to rare type of leukemiaWASHINGTON, August The U.S buy priligy uk . Department of Health and Human Services ‘ Food and Drug Administration has the following news release:The U.S. Food and Drug Administration today Marqibo in adults negative with a rare form of leukemia called Philadelphia chromosome acute lymphoblastic leukemia treated. ALL is a rapidly progressing form of blood and bone marrow cancer, more common in children than in adults is diagnosed. According the National Cancer Institute, are estimated at 6,050 men and women diagnosed with ALL and 1,440 die from the disease this year. Marqibo is for patients whose leukemia has come back two or more times, or their leukemia after two or more treatments of anti – leukemia therapy progressed approved. Marqibo containing vincristine, a commonly used anti-cancer drug included in a liposome, a drug delivery carrier material similar to that of the cell membrane consists. It is a once a week injection be administered by a doctor. Marqibo consent shows the FDA ‘s commitment to the development and approval of drugs, the serious, unmet medical needs, said Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA Center for Drug Evaluation and Research. Marqibo provides an additional option for Philadelphia chromosome – negative acute lymphoblastic leukemia patients that are no longer available therapies. Marqibo under accelerated approval from the FDA program that the agency of a drug, a serious illness on clinical data showing that the drug has an effect on a surrogate endpoint predict with high probability clinical benefit has has may approve approved to treat basis. This program provides earlier patient access to promising new drugs while the company will conduct additional clinical trials for the drug to confirm clinical benefits and safety use. Marqibo received orphan product by the FDA, 15.4 per centis intended to treat a rare disease or condition. The effectiveness of the drug was evaluated in a single clinical trial in adult patients whose leukemia had relapsed at least twice despite standard treatments, and who had at least one previous response to treatment takes at least 90 days. The goal of the study was to determine the response rate Marqibo, either as complete remission or complete remission with incomplete blood count recovery . Enrolled from 65 patients responded, 10 patients, or 15.4 %, with either a CR or CRi. In the 10 patients with a CR or CRi, the median duration of remission documented 28 days. The median time to first event of relapse was the death or therapy next 56 days. The security of the two-armed Marqibo was evaluated in tests on 83 patients receiving the clinical treatment regime. Serious adverse events, such as low white blood cell count with fever, low blood pressure, shortness of breath and cardiac arrest was studied in 76 % of patients. Marqibo trials studies include constipation, nausea, low blood cell, nerve damage, fatigue, diarrhea, loss of appetite and insomnia. Prescribing information for Marqibo carry a boxed warning alerting patients and health care professionals that the drug must be administered through a vein , because it is deadly if. In other ways, as administered in the cerebrospinal fluid The boxed warning also notes that Marqibo different dosage recommendations as vincristine sulfate injection alone. An overdose an overdose, it is important that health care professionals name name of the drug and the dose before administration. Specific requirements for the manufacture of the drug are described in detail in the label. Marqibo of Talon Therapeutics Inc., South San Francisco, California.
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