FDA lifts hold on NeoRx' STR (Skeletal Targeted Radiotherapy) programme:
This article was originally published in Clinica
Executive Summary
The US FDA has lifted its hold on the further development of NeoRx' Skeletal Targeted Radiotherapy (STR) product for treating multiple myeloma, a cancer of the bone marrow. The agency's decision follows NeoRx's submission of data from a dosimetry study of STR, which had been requested by the FDA. The Seattle, Washington firm said that it intended to submit a phase III study protocol before the end of the second quarter of 2003 for review by the FDA. Three-year survival data on the STR phase I/II patients is expected to become available by the end of this year.