You are here
FDA Lifts Clinical Hold on Skeletal Targeted Radiotherapy
The FDA’s decision follows NeoRx’s submission of data from a dosimetry study of STR, in which multiple myeloma patients were treated and detailed radiation dosimetry data were collected, as previously requested by the FDA. NeoRx continues to follow these patients for safety and efficacy results. Three-year survival data on the STR Phase I/II patients will be available by the end of 2003.
NeoRx also has submitted to the FDA a proposal for further clinical development of STR, and expects to submit a full Phase III study protocol before the end of the second quarter of this year for the FDA’s review.
“This is certainly good news for multiple myeloma patients and their physicians. STR is the only therapeutic in late-stage development that has demonstrated a significant complete response rate and offers the potential for prolonged progression-free survival and overall survival,” said William Bensinger, MD, Member, Fred Hutchinson Cancer Research Center (Seattle), Co-Principal Investigator and member of the Company’s Clinical Advisory Panel for STR.
“This decision is a major milestone for NeoRx. With the clinical hold lifted, and additional funds in hand from recent intellectual property agreements, we are at a turning point. We look forward to working with the FDA to finalize plans for the STR clinical program, and to enrolling multiple myeloma patients in further studies of this promising therapeutic,” said Jack L. Bowman, Executive Chairman and Chairman of the Board of Directors of NeoRx.