Clipping of news on Brazilian Culture, Law and Citizenship
10/08/2012
This article was translated by an automatic translation system, and was therefore not reviewed by people.
Remedy is indicated for patients whose acute lymphoblastic leukemia is relapsed or progressed after two or more treatments
The Food and Drug Administration (FDA) approved the drug Marqibo to treat adults with a rare type of leukemia called acute lymphoblastic (ALL) Philadelphia chromosome negative.
The new drug is indicated for patients whose leukemia has returned twice or more, or whose disease progressed after two or more treatments.
Marqibo vincristine contains a commonly used anticancer drug placed within a liposome delivery vehicle composed of material similar to cell membranes. The drug is supplied through an injection given once per week for a health care professional.
"The approval of Marqibo demonstrates the commitment of the agency for the development and approval of drugs that treat serious unmet medical needs. The product offers an additional option for this rare type of disease that is unresponsive to available treatments," said Richard Pazdur, the FDA.
The drug efficacy was evaluated in one trial to adult patients who had relapsed at least twice while the standard treatments. The aim of this study was to determine the response rate to Marqibo as complete remission (CR) or complete remission with incomplete blood count recovery (CRI).
Of the 65 patients included 10 patients, or 15.4% responded with CR or CRI. In the 10 patients who achieved CR or CRI, the average duration of remission was documented in 28 days.
The safety of Marqibo was evaluated in two trials with 83 patients who received the clinical treatment. Serious adverse events, such as low white blood cell count, fever, low blood pressure, difficulty breathing and cardiac arrest occurred in 76% of patients.
Source: Journal of Health
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This article was translated by an automatic translation system, and was therefore not reviewed by people.