Spectrum Pharmaceuticals to submit additional data for FUSILEV sNDA

Spectrum Pharmaceuticals (NasdaqGM: SPPI), a commercial-stage biotechnology company with a primary focus in oncology, today announced that it has met with the FDA regarding it’s supplemental New Drug Application (sNDA) for FUSILEV^® (levoleucovorin) for injection for the treatment of patients with advanced metastatic colorectal cancer. In October 2009, the FDA issued a Complete Response letter regarding its sNDA for FUSILEV.

“We currently expect to provide the FDA with the additional data they require to complete their review of FUSILEV for the treatment of advanced metastatic colorectal cancer in the third quarter.”

The FDA requested additional data which the Company expects to submit in the third quarter of 2010. The FDA did not request any additional efficacy studies.

“We are very encouraged by the collaborative relationship and straightforward requirements for approval posed to us by the FDA,” said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. “We currently expect to provide the FDA with the additional data they require to complete their review of FUSILEV for the treatment of advanced metastatic colorectal cancer in the third quarter.”