The FDA is informing the public that it is conducting an ongoing safety review of clinical trial data suggesting that patients treated with Revlimid (lenalidomide; Celgene) may be at an increased risk of developing new types of cancer compared with patients who did not take the drug.
Watson and GeneraMedix announced that Nulecit, a generic of Ferrlecit (sodium ferric gluconate complex in sucrose injection; sanofi-aventis), has been approved for the treatment of iron deficiency anemia in patients ≥6 years undergoing chronic hemodialysis who are receiving supplemental epoetin therapy.
Tris Pharma announced that it has acquired and relaunched the MyKidz Iron product line.
Genzyme announced data from its Phase 2 study of eliglustat tartrate for the treatment of Gaucher disease type 1.
Celgene announced Phase 2 clinical data results from two investigational studies evaluating the combination of Revlimid (lenalidomide) plus Rituxan (rituximab, from Genentech) for the treatment of indolent non-Hodgkin’s lymphoma (NHL).
Glycomimetics announced results from its Phase 1/2 study of GMI-1070 for the treatment of sickle cell disease.
Intravenous iron should be used for the treatment of patients with cancer-related anemia; those treated have better hematopoietic response and less need for transfusion, with no difference in mortality or adverse events, according to a study presented at the 52nd American Society of Hematology Annual Meeting and Exposition.
Transfusion therapy in adults with sickle cell disease (SCD) is safe and improves or stabilizes critical laboratory markers, decreases serious sickle cell anemia-related adverse events, and decreases hospitalizations, preliminary data from the first prospective randomized study of the safety and efficacy of transfusion therapy in adults with SCD has found. The study was presented at the 52nd American Society of Hematology Annual Meeting and Exposition.
When compared with using erythropoiesis-stimulating agents (ESA) alone or placebo, iron supplementation of ESAs significantly increases hematopoietic response rates and reduces the number of red blood cell (RBC) transfusions in patients with chemotherapy-induced anemia (CIA), results of the first systematic review and meta-analysis have found. The study was presented at the 52nd American Society of Hematology Annual Meeting and Exposition.
FDA is requiring that Erythropoiesis-Stimulating Agents (ESAs) be prescribed and used under a special risk management program.
