Spectrum receives FDA approval for FUSILEV to treat 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.