RayzeBio, aradiopharmaceutical company developing innovative products aimed at treating solid tumor targets, announced that the FDA has selected RYZ101 (Actinium-225 DOTATATE) 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 (SSTR+) gastro-entero-pancreatic neuroendocrine tumors (GEP-NETs) that have progressed following prior Lutetium-177 labelled somatostatin analogue therapy.

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FDA Selected RAYZEBIO to Participate in the Inaugural CDRP Program to Expedite Commercial Manufacturing Readiness for RYZ101 in GEP-NETS

Source: RAYZEBIO