FDA denies Lantheus’ application for new PET imaging agent
The U.S. Food and Drug Administration recently denied drugmaker Lantheus’ application for a new PET imaging agent, citing concerns over issues at a third-party manufacturing site.
The Bedford, Massachusetts-based company has for months sought to roll out LNTH-2501—a radioactive diagnostic kit for localizing neuroendocrine tumors. Lantheus previously reported setbacks with the product in March, targeting a Prescription Drug User Fee Act date of June 29.
However, Lantheus said Friday that this goal is no longer feasible, given the FDA’s response.
“We remain confident in LNTH-2501 and are committed to bringing this imaging agent to [neuroendocrine tumor] patients and healthcare providers as soon as possible,” CEO and Chair Mary Anne Heino said in a statement June 26. “The feedback received from the FDA relates solely to our third-party manufacturer and not to the clinical performance of the product. We are working closely with our partner and the agency to address these facility manufacturing-related conditions and advance the program.”
LNTH-2501 (Gallium 68 edotreotide) is an investigational product indicated for use with positron emission tomography. Its meant for localization of somatostatin receptor-positive tumors in both adult and pediatric patients. The product is supplied as a two-vial kit to radiopharmacies, allowing for direct preparation of Ga 68 edotreotide injection with the eluate of Gallium from an on-site generator at the radiopharmacy. Neuroendocrine tumors, meanwhile, 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, experts note. About 4 in every 100,000 adults are impacted by the condition, according to the NIH.
Lantheus’ shares were down slightly following the news, Reuters reported. Truist analyst Richard Newitter, however, said he does not view the denials as a meaningful setback.
“We would be buyers of the stock particularly on any weakness related to this update," he told the outlet.
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.