Lantheus receives tentative FDA approval for its radio-equivalent to Lutathera
Lantheus’ version of a radiopharmaceutical capable of targeting somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) has been tentatively approved by the U.S. Food and Drug Administration.
The radiopharmaceutical-focused company announced the tentative approval of its Abbreviated New Drug Application for Lutetium Lu 177 Dotatate (PNT2003). The drug is described as the “radio-equivalent version of Lutathera (lutetium Lu 177 dotatate),” which is manufactured by Advanced Accelerator Applications, a Novartis company.
GEP-NETs grow slowly. As such, they often go undetected for an extended amount of time. Incidence rates of these tumors have risen substantially in recent years, which has caused the demand for treatment to climb as well.
Mary Anne Heino, chief executive officer of Lantheus, is hopeful that by bringing an additional radiopharmaceutical option to the market, more patients will have access to treatment.
“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,” Heino said in a statement.
The drug’s tentative approval suggests it has met the FDA’s requirements for approval under the Federal Food, Drug and Cosmetics Act. Full approval is expected to come through by June of this year.
The news comes just two months after Lantheus announced the sale of its SPECT business to Shine Technologies—a Janesville, Wisconsin-based fusion firm. At the time of the sale, Lantheus indicated the move was intended to allow the company to focus more on its growing radiopharmaceutical and microbubble endeavors.
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In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.