The FDA has requested data from additional clinical trials to demonstrate the benefit of the drug.
In anticipation of a not approvable letter from the FDA, the company announced in July that it would amend the current NDA with additional survival data with the goal of bringing the mifamurtide (L-MTP-PE) to market as quickly as possible.
“While the FDA has asked for data from additional clinical trials, we believe that this decision was made in context of the lack of complete data in the submitted NDA and that capturing supplemental data will overcome the need for additional trials and further confirm the overall survival benefit of L-MTP-PE in osteosarcoma and provide evidence for approvability,” explained Timothy Walbert, president and CEO of IDM Pharma.
The company will continue working with the cooperative groups and investigative sites involved in the study to collect vital status (information on whether the subjects remain alive or have died) on patients who participated in the Phase III clinical trial and for whom complete data were not available at the time of filing of the NDA in October 2006.
When the additional follow up data have been collected, the company will analyze the data and expects to submit an amendment to the NDA to the FDA by the first quarter of 2008.