Fusilev levoleucovorin regulatory update

FDA accepted for review a response from Spectrum to a 2009 complete response letter for an sNDA for Fusilev levoleucovorin injection to treat advanced metastatic colorectal cancer (mCRC). FDA designated the response as a Class 2 resubmission and set a PDUFA date of April 29, 2011. In its complete response letter, FDA had suggested that the company's sNDA did not demonstrate Fusilev's non-inferiority to leucovorin (see BioCentury, Oct. 12, 2009). ...