Allos Therapeutics Inc has submitted to the U.S. Food and Drug Administration (FDA) the second of three data components of the New Drug Application (NDA) for its radiation sensitizer, RSR13 (efaproxiral), for the treatment of patients with metastatic breast cancer. The electronic submission was produced in an internationally agreed upon format that facilitates regulatory review in the United States, Europe and Japan.
The submission is taking place on a "rolling" basis, which allows Allos to submit portions of the NDA as they are completed. The first part of the application containing non-clinical information was submitted on August 5, 2003. The second part of the NDA contains information about the drug's chemistry, manufacture and controls (CMC). The final portion of the NDA will contain the findings from recent clinical studies, which will form the core of the submission.
"The positive results with RSR13 seen in patients with metastatic breast cancer in our Phase 3 randomized clinical trial and the drug's favorable safety profile suggest that RSR13 could be a valuable complement to radiation therapy -- the current standard of care," said Michael E. Hart, President and CEO of Allos Therapeutics, Inc. "Our team is focused on completing the NDA quickly and efficiently with the goal of submitting the final clinical section to the FDA by the end of this year."
When complete, the NDA submission will contain safety and efficacy data from over 700 patients treated with RSR13 under seventeen 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.