Cancer drug developer Spectrum Pharmaceuticals, Inc, said the FDA has extended the date for completing review of its osteogenic sarcoma drug ISO-Vorin (levofolinic acid, or LFA) for injection NDA. The federal regulators extended the dates by 60 days to March 7, 2008.

ISO-Vorin is the pure active isomer of calcium leucovorin. Calcium leucovorin is used after the administration of high-dose methotrexate in treating osteogenic sarcoma and is also a component of "standard of care" 5-fluorouracil (5-FU) containing regimens for the treatment of colorectal cancer and other malignancies. Wyeth, Sanofi-Aventis, and others, currently market LFA in certain parts of the world, including Europe and Japan. Peak sales for LFA outside the United States were nearly $200 million.

Spectrum Pharmaceuticals acquires, develops and commercializes a diversified portfolio of oncology drug candidates that meet critical health challenges for which there are few other treatment options. The company's pipeline includes promising early and late-stage drug candidates with unique formulations and mechanisms of action that address the needs of seriously ill patients, such as at-home chemotherapy and new treatment regimens for refractory disease.