RayzeBio announces FDA selected RYZ101 into CMC CDRP program

RayzeBio announced the FDA has selected RYZ101 into the inaugural Chemistry, Manufacturing, and Controls, CMC, Development and Readiness Pilot, CDRP, program. The CDRP program was created by the FDA to facilitate CMC readiness for selected therapies with accelerated clinical development timeframes based on the anticipated clinical benefits of earlier patient access to the therapy. Under the program, the FDA will work closely with RayzeBio to facilitate CMC development of RYZ101 for the treatment of somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors that have progressed following prior Lutetium-177 labelled somatostatin analogue therapy. “We applaud the FDA for undertaking this initiative to partner with pioneers in emerging modalities. We are making significant investments to ensure commercial readiness for RYZ101, including building our own manufacturing facility in Indianapolis. RYZ101 has already demonstrated encouraging preliminary response data and is now enrolling in a registrational Phase 3 clinical trial. We are eager to collaborate with the FDA as we aim to develop and bring this important therapy to market,” said Ken Song, M.D., President and CEO of RayzeBio.