Allos Therapeutics Inc has begun submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the company's investigational radiation sensitizer, RSR13 (efaproxiral), for the treatment of patients with breast cancer that has metastasized to the brain. The electronic submission was produced in the Common Technical Document format, which is an internationally agreed upon format that facilitates regulatory review in the USA, Europe and Japan. The submission will occur on a "rolling" basis and is expected be completed by the end of the year. The first component submitted contained the nonclinical section, consisting of one CD-ROM containing 40 volumes and over 6,900 pages of data and analysis. The chemistry, manufacturing and controls (CMC) and the clinical modules will be submitted later this year.
When complete, the NDA submission will contain safety and efficacy data from over 700 patients treated under 17 RSR13 study protocols and will be based largely on the company's recently completed pivotal Phase 3 clinical trial, one of the largest randomized studies ever conducted in patients with brain metastases. The submission will also include supporting data from three Phase 2 studies of RSR13 in patients with brain metastases, primary non-small cell lung cancer and glioblastoma multiforme.
"The submission of the first section of our NDA to the FDA is an extremely gratifying milestone for an emerging company like Allos," said Michael E. Hart, President and CEO of Allos Therapeutics, Inc. "There is clearly an unmet medical need for new treatments that can provide better local control of brain metastases while extending survival. This hypothesis was confirmed by the results of the Phase 3 trial, demonstrating a significant survival benefit in patients with metastatic breast cancer. Our goal is to get RSR13 into the hands of oncologists that treat patients as quickly as possible. To help facilitate this process, we are in ongoing discussions with the FDA regarding future development of RSR13 as a radiation sensitizer."