Shares of Irvine drug maker Spectrum Pharmaceuticals Inc. fell sharply Friday after a regulatory setback.
Spectrum shares closed down about 18% with a market value of about $213 million.
The Food and Drug Administration declined Spectrum’s request to expand the usage of its Fusilev drug to colon cancer.
Fusilev, which Spectrum launched last year, is used to guard healthy cells from chemotherapy for osteosarcoma, a rare form of bone cancer.
Spectrum also sells Zevalin, a drug to treat non-Hodgkin’s lymphoma, a blood cancer.
The company applied last year for approval to use Fusilev in combination with other drugs for advanced metastatic colorectal cancer.
Spectrum said in a release that the FDA didn’t think that its submission for Fusilev proved that it was as good as leucovorin, which is the current drug used to treat the disease.
The company said that regulators recommended a meeting to discuss options for continuing to seek approval for expanded Fusilev usage, and that it would promptly request such a meeting.
