Published on January 25, 2010 at 7:47 AM
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.”
SOURCE Spectrum Pharmaceuticals