Spectrum gets FDA response letter on cancer drug
Fri Oct 9, 2009 7:01am EDT
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* Says will request meeting with FDA
* Says FDA did not request changes to current indications
Oct 9 (Reuters) - Spectrum Pharmaceuticals (SPPI.O) said it received a complete response letter from U.S. health regulators regarding its supplementary marketing application for its drug, Fusilev, to treat advanced metastatic colorectal cancer.
Spectrum, which received marketing approval for its another cancer drug last month, said it plans to request a meeting with the U.S. Food and Drug Administration to discuss options for approval of Fusilev.
Fusilev is currently approved by the FDA as a rescue after high dose of methotrexate therapy in patients with osteosarcoma, a type of bone cancer.
Fusilev is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonist, a type of chemotherapy.
Spectrum said the FDA did not request any changes to the currently approved indications and package insert.
