Biotechnology company Spectrum Pharma. (SPPI) said Friday that the U.S. Food and Drug Administration refused to approve its supplemental New Drug Application for a new indication of Fusilev, and that the agency is seeking a meeting with the company to discuss options for continuing to seek approval. The company's stock lost over 15% in pre-market, and currently trades down by more than 16% on the Nasdaq.
The Irvine, California-based company was seeking approval from the FDA for Fusilev for injection for treatment of patients with advanced metastatic colorectal cancer.
The company received a Complete Response Letter from the FDA today, which conveyed that the sNDA submission did not demonstrate non-inferiority of Fusilev over leucovorin. Leucovorin is an adjuvant used in cancer chemotherapy involving methotrexate, to prevent harmful effects of methotrexate.
Fusilev is currently FDA approved and marketed for rescue after high-dose methotrexate therapy in osteosarcoma, to diminish the toxicity and counteract the effects of impaired methotrexate elimination and inadvertent overdosage of Folic Acid antagonists. Fusilev, or levoleucovorin, marketed outside the U.S. by Wyeth, Sanofi-Aventis, Takeda, and others for more than a decade.
Spectrum noted that it plans to promptly request a meeting with the FDA to discuss the options for approval of Fusilev in advanced metastatic colorectal cancer.
The agency has not requested any changes to the currently approved indications and package insert of Fusilev.
SPPI is currently trading down 16.74% at $5.17, on the Nasdaq.
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