Spectrum's Fusilev gets US knock-back in colorectal cancer
This article was originally published in Scrip
Executive Summary
The US FDA has denied approval to Spectrum Pharmaceuticals' chemotherapy drug Fusilev (levoleucovorin; previously ISO-Vorin) for advanced metastatic colorectal cancer. The agency has issued a complete response letter saying that the submission "did not demonstrate that Fusilev is non-inferior to leucovorin" and recommended a meeting with the company.