Lantheus (LNTH) said Tuesday that the US Food and Drug Administration granted final approval for Bravnetsa, a radiopharmaceutical equivalent to Lutathera, for adults with gastroenteropancreatic neuroendocrine tumors, a group of rare cancers affecting the digestive tract and pancreas.
The company said the FDA determined Bravnetsa is the only radiopharmaceutical that is both bioequivalent and therapeutically equivalent to Lutathera, the reference product.