FDA tentatively approves AND Application for Lutetium Lu 177 Dotatate (PNT2003) for the treatment of somatostatin receptor-positive GEP-NETs
“As the first radioequivalent to LUTATHERA to receive FDA tentative approval, PNT2003 marks an important step forward in Lantheus’ work to advance treatment options for patients with GEP-NETs. This milestone comes at a time when advances in imaging and evolving clinical guidelines are enabling the identification of more patients who stand to benefit from targeted radiopharmaceutical therapies. As the leading radiopharmaceutical-focused company, we remain committed to meeting this growing demand and look forward to making PNT2003 available to patients pending final FDA approval,” said Mary Anne Heino, Chief Executive Officer of Lantheus.
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