|FDA Says No to Spectrum|
|By Staff and Wire Reports|
|Friday, 09 October 2009 07:20|
Spectrum, which received a label expansion approval for another cancer drug last month, said it plans to request a meeting with the U.S. Food and Drug Administration to discuss options for the 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.
The drug 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.
The FDA stated in the Complete Response letter that the submission did not demonstrate that FUSILEV is non-inferior to leucovorin; and recommended that the Company meet with them to discuss options for continuing to seek approval of FUSILEV in advanced metastatic colorectal cancer. The Company plans to promptly request such meeting to discuss options for FUSILEV in this indication.
Spectrum shares were down in pre-market trading.