The FDA requested additional data which the company expects to submit in the third quarter of 2010. The agency did not request any additional efficacy studies.
Rajesh Shrotriya, MD, chairman, chief executive officer and president of Spectrum Pharmaceuticals, said: “We are very encouraged by the collaborative relationship and straightforward requirements for approval posed to us by the FDA. We currently expect to provide the FDA with the additional data they require to complete their review of Fusilev for the treatment of advanced metastatic colorectal cancer in the third quarter.”
Fusilev, a novel folate analog, is available in vials as freeze-dried powder. Fusilev rescue is also indicated after high-dose methotrexate therapy in osteosarcoma. Additionally, it is indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists.