Antonio Maldonado, Member of the SNMMI Committee on Continuing Education, shared on LinkedIn:
“The FDA has granted final approval for Bravnetsa, the only radiopharmaceutical to be designated as bioequivalent and therapeutically equivalent to Lutathera, its reference product.
Bravnetsa, or lutetium Lu 177 dotatate, was approved to treat adult patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors and was supported by data from the Phase 3 NETTER-1 trial and the ERASMUS Medical Center trial.
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FDA Updates Regulations to Expand Alternatives to Animal Testing in Drug Development
