Neoprobe, a developer of oncology surgical and diagnostic products, has completed a pre-NDA (new drug application) assessment for Lymphoseek, a radiopharmaceutical agent, with the US Food and Drug Administration (FDA).
As a result of the pre-NDA assessment, FDA has requested that data from both the completed NEO3-05 study and the NEO3-09 study currently in progress to be included in the company’s primary NDA for Lymphoseek rather than submitting the NEO3-09 study data as a major amendment to the ongoing NDA review.
NEO3-09 was intended as a supplement to the primary NDA for Lymphoseek for safety evaluation purposes and to support expanded product labeling claims.
The pre-NDA assessment resulted in no modification to the NEO3-09 trial design or endpoints or to any of the other previously agreed-to clinical or regulatory components of the Lymphoseek NDA.
Neoprobe president and CEO David Bupp said that the firm has agreed to FDA’s request to include safety and efficacy data for Lymphoseek from both clinical trials to ensure that the Agency has the requested information to conduct a complete first-cycle review of the NDA for Lymphoseek.
“We believe the earlier than originally planned inclusion of the NEO3-09 study data will support stronger product labeling as an outcome of a first-cycle review of the Lymphoseek NDA and may also positively impact market adoption,” Bupp said.