CORRECTED - CORRECTED-UPDATE 1-Spectrum says FDA refuses to OK new plea on c
(Corrects second bullet point and paragraph 5 to clarify that the drug Fusilev failed to show non-inferiority to standard drug)
* Says will request meeting with FDA
* Says drug fails to show non-inferiority to standard drug
* Says FDA did not request changes to current indications
* Shares fall 17 pct (Recasts, adds details, share movement)
Oct 9 (Reuters) - Spectrum Pharmaceuticals (SPPI.O) said U.S. health regulators declined to approve its supplementary marketing application for its advanced metastatic colorectal cancer drug Fusilev in its current form, sending its shares down more than 17 percent.
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.
Spectrum said the FDA noted that the submission did not show that Fusilev is non-inferior to standard treatment leucovorin, and it did not request any changes to the currently approved indications.
Spectrum shares were down $1.08 at $5.13 in pre-market trade. They closed at $6.21 Thursday on Nasdaq. (Reporting by Anand Basu in Bangalore; Editing by Gopakumar Warrier)
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