FDA Update: May/June 2012

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Use of lenalidomide (Revlimid) increases the risk of second primary malignancies in persons with newly diagnosed multiple myeloma, according to a safety review update from the FDA. Clinical trials conducted after the drug was approved in July 2006 showed an increased risk of acute myelogenous leukemia (AML), myelodysplastic syndromes, and Hodgkin lymphoma among these patients. 

A pooled analysis demonstrated that 65 second primary malignancies developed among 824 patients (7.9%) with newly diagnosed multiple myeloma who received initial chemotherapy or chemotherapy plus blood stem-cell transplantation followed by treatment with lenalidomide. Only 19 such malignancies developed in the 665 patients (2.8%) taking placebo. 

Pazopanib (Votrient) has received FDA approval for use as a treatment for persons with advanced soft-tissue sarcoma (STS) who have undergone prior chemotherapy. The oral tyrosine kinase inhibitor was approved for the treatment of advanced renal cell carcinoma in adults in 2009.

The US label of Votrient specifies that the efficacy of the drug for adipocytic STS or gastrointestinal stromal tumors has not been demonstrated.

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