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FDA Delays Cancer Scan Kit Review
18 Mar
Summary
- FDA extended review of Lantheus diagnostic kit by three months.
- Review delay is for manufacturing information, not safety or efficacy.
- Kit aims to detect neuroendocrine tumors using PET scans.
The U.S. Food and Drug Administration has extended its review period for Lantheus Holdings' diagnostic imaging kit, LNTH-2501. The review, now slated for completion by June 29, has been pushed back by three months.
This extension is specifically for the FDA to review additional manufacturing-related information provided by Lantheus. Company officials have clarified that the delay is unrelated to the kit's safety or efficacy findings.
The LNTH-2501 is a diagnostic tool designed to aid physicians in the detection of neuroendocrine tumors, often referred to as NETs. Its intended use involves PET scans, a medical imaging technique that offers detailed internal views of the body.
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