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news.Navidea Biopharmaceuticals has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for its New Drug Application (NDA) for Lymphoseek(technetium Tc 99m tilmanocept) injection due to manufacturing deficiencies.
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The FDA in the CRL said it focused on issues with third-party Lymphoseek contract manufacturing and was not in relation to any efficacy or safety data filed within the Lymphoseek NDA.
Lymphoseek, which is a receptor-targeted radiopharmaceutical, is designed to identify the lymph nodes that drain from a primary tumor.
Navidea Biopharmaceuticals president and CEO Mark Pykett said Navidea believes that Lymphoseek helps improve the lives of patients who undergo lymphatic mapping procedures to stage solid tumor cancers, such as breast cancer and melanoma.
"We are already working closely with the FDA and our third-party contract manufacturers to address all requirements to support the shortest possible NDA resubmission and review,” Pykett added.
”We remain confident that our clinical data clearly demonstrate the value of Lymphoseek in accurately identifying lymph nodes that most likely harbor cancer while producing no clinically significant adverse effects."