FDA Approves Fusilev® For Use In Patients With Colorectal Cancer
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, received approval from the U.S. Food and Drug Administration (FDA) on April 29, 2011, for the use of FUSILEV® (levoleucovorin) in combination with 5-fluorouracil in the palliative treatment of patients with advanced metastatic colorectal cancer. This new, expanded indication supplements the original 2008 FDA approval of FUSILEV.
“We are pleased that the FDA has approved FUSILEV for use in colorectal cancer,” said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. “Although the NCCN Guidelines in the United States already recommend levoleucovorin in the treatment of colorectal cancer patients, we could not promote FUSILEV for this indication until now. We believe that the FDA approval of FUSILEV in the treatment of colorectal cancer could represent a significant growth catalyst for Spectrum. In the United States, more than 90% of its clinical use is for the treatment of patients with colorectal cancer. FUSILEV, under various trade names, has been available in Europe and Japan primarily by Wyeth, Sanofi-Aventis, and Takeda Pharmaceuticals. It is estimated that ex-U.S. sales of FUSILEV are in excess of $180 million a year.”
According to the American Cancer Society, colorectal cancer is the third most commonly diagnosed cancer and the third leading cause of cancer death in both men and women in the US, with approximately 141,210 new cases and 49,380 deaths expected in 2011.
About FUSILEV® (levoleucovorin)
FUSILEV, a novel folate analog, is now approved as a ready-to-use (FUSILEV Injection) solution in 175 mg and 250 mg vials, and as freeze-dried powder (FUSILEV for Injection) in 50 mg vials. FUSILEV is indicated for use in combination with 5-fluorouracil in the palliative treatment of patients with advanced metastatic colorectal cancer. FUSILEV is also indicated for rescue after high-dose methotrexate therapy in osteosarcoma.
FUSILEV is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists. FUSILEV, under various trade names, is marketed outside the United States by Wyeth, Sanofi-Aventis, and Takeda.
Important FUSILEV® (levoleucovorin) Safety Considerations
FUSILEV is contraindicated for patients who have had previous allergic reactions attributed to folic acid or folinic acid. Due to calcium content, no more than 16-mL (160-mg) of levoleucovorin solution should be injected intravenously per minute. FUSILEV enhances the cyto-toxicity of fluorouracil. Concomitant use of d,l-leucovorin with trimethoprim-sulfamethoxazole for pneumocystis carinii pneumonia in HIV patients was associated with increased rates of treatment failure in a placebo-controlled study. Allergic reactions were reported in patients receiving FUSILEV. Vomiting (38%), stomatitis (38%) and nausea (19%) were reported in patients receiving FUSILEV as rescue after high dose methotrexate therapy. The most common adverse reactions (>50%) in patients with advanced colorectal cancer receiving FUSILEV in combination with 5-fluorouracil were diarrhea, nausea and stomatitis. FUSILEV may counteract the antiepileptic effect of phenobarbital, phenytoin and primidone, and increase the frequency of seizures in susceptible patients.
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http://www.FUSILEV.com