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FDA: Revlimid Linked to Second Cancers – in Oncology/Hematology, Myeloma from MedPage Today.

Treatment of multiple myeloma with lenalidomide (Revlimid) as maintenance therapy is associated with an increased risk of second primary cancers, the FDA warned.

In three trials involving newly diagnosed patients initially treated with chemotherapy and stem cell transplantation, followed by maintenance lenalidomide or a placebo, the risk of a second primary cancer was increased about threefold, the agency said.

Trials involving relapsed/refractory patients – on which the drug's initial approval was based – did not show a significant increase in risk after adjustment for the length of time patients took the drug, the agency said.

A pooled analysis of the three maintenance trials showed that, as of Feb. 28, 2011, there had been 65 second primary malignancies among 824 lenalidomide patients and 19 among 665 patients in the treatment arms that did not include the drug. Read More


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Texas legitimizes path around FDA oversight : Nature Biotechnology
Governor Rick Perry lends a hand to stem cell therapies. On April by local institutional review boards in lieu of US Food and Drug Administration (FDA) review.

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Neuralstem Updates ALS Stem Cell Trial Progress – Health News
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