SPPI Class 1 Response is a good sign

Spectrum Pharmaceuticals (SPPI) received a Class 1 response from the FDA today on their resubmission of data on Zevalin, SPPI's clinical non-Hodgkin's Lymphoma (NHL) drug. A Class 2 response could have meant a delay of up to 6 months for further FDA review. Instead, SPPI disclosed September 7 as the FDA decision date for approval. On July 2, the FDA requested additional data via a Complete Response Letter on SPPI's application for Zevalin's expanded use as first-line treatment for NHL. Currently, Zevalin is only approved for refractory, relapsed NHL. Zevalin is already approved in Europe for expanded labeling, so FDA approval is expected by many.

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SPPI also has another late-stage clinical drug coming up for FDA approval. Fusilev is already approved for osteocarcinoma, but is up for approval for treating colorectol cancer on October 8.