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Daretabart (hu1418K322A), developed by Renaissance Pharma Limited, a subsidiary of Essential Pharma, for the treatment of high-risk neuroblastoma, has received Fast Track designation from the FDA and passed IND review.
The FDA has granted Daretabart (hu1418K322A) Fast Track designation to address a significant unmet medical need in the field of high-risk neuroblastoma, allowing the drug to enter an expedited review and rolling review process. Following the FDA's approval of the Investigational New Drug (IND) application, the SHINE II/III phase clinical trial can be initiated among patients with recurrent and refractory high-risk neuroblastoma. The first commercial-scale GMP production batch of Daretabart (hu1418K322A) has been successfully completed. Based on positive data from Phase II trials, the overall survival rate of patients reached
Renaissance Pharma Limited, an Essential Pharma Company, Secures FDA Fast Track Designation and IND Clearance for Daretabart (Hu1418K322A) in High-risk Neuroblastoma
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