Spectrum Feeling Ill Effects of FDA Rejection: BioBuzz

IRVINE, Calif. (TheStreet) -- Spectrum Pharmaceuticals(SPPI Quote) is still feeling the ill effects Monday of Friday's decision by the Food and Drug Administration to reject the company's request for an expanded approval of its current cancer drug Fusilev to include treatment for colon cancer.

Spectrum shares are trading around $5 in Monday intraday trading. The stock is off 40% since nearing $9 in early September.

Fusilev's push into colon cancer isn't dead but it is likely to be significantly delayed, which isn't welcome news for Spectrum. Amar Singh, Spectrum's chief commercial officer, told me Friday that the company had been counting on its sales force having two drugs in their bags to detail to oncologists: Fusilev and the lymphoma drug Zevalin.

"Some shifting of internal resources will have to take place now," he said.

Whatever money Spectrum may save on Fusilev marketing may have to be spent -- and then some -- on a new colon cancer study of Fusilev. Singh says the company is trying to schedule a meeting with the FDA to find out what it will take to get Fusilev approved in colon cancer.

"We're not exactly sure what FDA wants yet, so it's premature to speculate," says Singh.

Fusilev is currently approved for a form of bone cancer, but annual sales are minimal. Expansion into colon cancer represents a more significant commercial opportunity for the drug.

Spectrum submitted to the FDA a 10-year-old study that failed to show the superiority of Fusilev over leucovorin, the predeccesor chemotherapy drug that Spectrum would like Fusilev to replace. Spectrum was only seeking an FDA determination that Fusilev and leucovorin were equivalent, but FDA wasn't convinced, apparently.