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FDA Approval for LEVOleucovorin for Osteosarcoma; Priority Review for Promacta for ITP

doi: 10.1097/01.COT.0000317227.94078.5c
Original Article

The FDA has approved the use of LEVOleucovorin for Injection after high-dose methotrexate therapy in patients with osteosarcoma, and to reduce the toxicity and counteract the effects of impaired methotrexate elimination or unintentional overdose of folic acid antagonists.

LEVOIeucovorin will be supplied in 50 mg vials of freeze-dried powder and is currently listed as a replacement for calcium leucovorin in the NCCN Clinical Practice Guidelines. The manufacturer, Spectrum Pharmaceuticals, noted in a news release that the plan is to file for a supplemental New Drug Application (NDA) for the use of the drug in colorectal cancer in fluorouracil-containing regiments as well as an NDA amendment for an oral tablet form by the middle of the year.

Promacta (eltrombopag) was granted Priority Review for the short-term treatment of chronic idiopathic thrombocytopenic purpura (ITP). The drug is a once-daily oral therapy that induces the production of cells in the bone marrow to generate platelets, which are essential for minimizing the incidence of bleeding in chronic ITP. If approved, eltrombopag would be the first oral thrombopoeitin receptor agonist for the short term-treatment of previously treated patients with the condition.

In early studies, the most common adverse events observed in patients taking eltrombopag were headache, nausea, nasopharyngitis, diarrhea, and vomiting. The drug is also being studied for long-term treatment of chronic ITP, as well as thrombocytopenia associated with hepatitis C virus cirrhosis, and chemotherapy-induced thrombocytopenia.

© 2008 Lippincott Williams & Wilkins, Inc.
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