Breast Cancer

Second part of rolling NDA submitted for RSR13

Published in Cancer Weekly, October 28th, 2003

Allos Therapeutics, Inc., (ALTH) announced that it 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...

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Source: Cancer Weekly (2003-10-28)

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