FDA pushes back its review of new PET imaging agent from Lantheus
The U.S. Food and Drug Administration is extending its review of a new PET imaging agent from vendor Lantheus.
The Bedford, Massachusetts-based drugmaker announced the news on Tuesday, with the three-month delay pertaining to LNTH-2501.
Lantheus said the radioactive diagnostic kit is indicated for use with positron emission tomography for localization of neuroendocrine tumors in both adult and pediatric patients. LNTH-2501 is offered as a two-vial kit, allowing for direct preparation of Ga 68 edotreotide injection from an on-site generator at the radiopharmacy.
“LNTH-2501 is not currently approved by the FDA and is not yet available for sale in the United States,” the company emphasized.
Lantheus is now targeting a Prescription Drug User Fee Act date of June 29. The delay will give the FDA additional time to review and consider further info related to the drug’s review. Lantheus also emphasized that the extension is “not related to the efficacy or safety” of LNTH-2501.
Neuroendocrine tumors are a rare type of cancer that blends both nerve and hormone-producing characteristics. They can arise anywhere in the body but most commonly emerge in the digestive tract or lungs.
The delay is a disappointment for investors, Reuters reported. However, those who follow the company closely are “nevertheless relieved that the extension is not related to the clinical profile,” Andy Hsieh, an analyst with financial services firm William Blair, wrote in a research note. He expects the imaging agent to launch in the third quarter, with about $2 million in projected sales for Q3 and $5 million for Q4, Reuters noted. Lantheus (LNTH) was down slightly Wednesday, trading at approximately $80.45 at the previous market close.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.