Navidea Biopharmaceuticals has received notification from the FDA that the Prescription Drug User Fee Act (PDUFA) date for 99m-Tc-Tilmanocept (Lymphoseek) has been pushed back to Sept. 10, a 90-day extension from the initial PDUFA date of June 10. Lymphoseek is an investigational radioactive tracing agent for lymphatic mapping and lymphoscintigraphy.
On March 30, the Dublin, Ohio-based company provided updated chemistry, manufacturing and control information related to one of several drug analytical assays, due to a request by the FDA. As this information was submitted within the 90-day period prior to the PDUFA date, on April 2, the FDA used its option to extend the review period by 90 days to complete a first-cycle evaluation.
Neither this FDA decision nor the New Drug Application (NDA) review-to-date has raised questions on Lymphoseek’s safety or efficacy, according to Navidea. The PDUFA date extension does not pertain to the company’s ongoing head and neck cancer clinical trial nor to the recently announced comparative analysis of Lymphoseek to sulfur colloid.
“We have submitted the information requested by the FDA in support of a first-cycle review of the Lymphoseek NDA,” said Mark J. Pykett, PhD, Navidea's president and CEO. “Our focus continues to be on supporting the FDA review and preparing for anticipated market introduction of Lymphoseek.”