The FDA dealt Lantheus’ bid to garner approval of its radiodiopharmaceutical diagnostic kit a setback due to manufacturing issues at a third-party facility.
The regulatory agency issued a complete response letter (CRL) that said it cannot approve the NDA for LNTH-2501 (Gallium 68 edotreotide) due to “unresolved third-party facility manufacturing-related conditions.”
The unnamed CDMO is responsible for drug product manufacturing, and a satisfactory resolution of the facility inspection-related conditions is required before the LNTH-2501 NDA may be approved, the company said in a June 26 press release.
No specifics related to the manufacturing issue were disclosed.
The FDA letter didn’t identify any concerns regarding the data submitted by Lantheus in support of the application, nor did it identify any issues related to the safety or efficacy of LNTH-2501, the company said.
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“We remain confident in LNTH-2501 and are committed to bringing this imaging agent to NETs patients and healthcare providers as soon as possible,” Mary Anne Heino, Lantheus’ executive chair and CEO, said in a statement. “The feedback received from the FDA relates solely to our third-party manufacturer, and not to the clinical performance of the product.”
Heino added that the company was working with the CDMO and the FDA to rectify facility manufacturing-related conditions in order to advance the program.”
LNTH-2501 is an investigational radioactive diagnostic kit designed to use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors in adult and pediatric patients. It is supplied as a 2-vial kit to radiopharmacies which allows for direct preparation of Ga 68 edotreotide injection with the eluate of Gallium from an on-site generator at the radiopharmacy.
The approval hiccup comes in the wake of reports late last month that Lantheus is contemplating a buyout offer from Curium Pharma that would value the deal at an estimated $7 billion although the company declined to comment on any pending acquisition.
