AAA today announced that the company has initiated an expanded access program (EAP) in the United States for the investigational product, Lutathera. Through the program, Lutathera is being made available for patients suffering from inoperable, somatostatin receptor positive, midgut carcinoid tumors, progressive under somatostatin analogue therapy. Healthcare professionals and patients can learn more about the Lutathera EAP by visiting www.clinicaltrials.gov (trial number: NCT02705313).
Today AAA also announced a New Drug Application (NDA) filing plan for Lutathera, following the pre-NDA meeting held on the 14 March 2016. Given that rolling submissions are possible under the Fast-Track program granted for Lutathera, the Agency accepted a submission plan in which all parts of the NDA are to be sent by the end of the current month except for the ISS and ISE (Integrated Summaries of Safety and Efficacy Databases) which should be submitted within thirty days after the bulk of the submission.
The review clock for the NDA will not begin until AAA informs the FDA that a complete NDA has been submitted, including the ISS and ISE. The rolling submission will, however, allow the FDA to immediately start the review of the most relevant parts of the application, including the separate Clinical Reports of both NETTER-1 and the Phase 2 study.
Given the fact that rolling submissions are not permitted at the European Medicine Agency (EMA), a complete submission to the EMA will be completed by the end of April.