Neoprobe Corp. has talked to the U.S. Food and Drug Administration about Phase 3 clinical study results for its cancer-detection drug and is beginning its new drug application (NDA).
The Dublin, Ohio, developer of oncology, and surgical diagnostic and treatment products completed its Phase 3 trial of Lymphoseek in early December. In the trial, Lymphoseek was 97 percent successful in identifying cancerous lymph nodes in patients with breast cancer or melanoma. The study’s goal was a 94 percent success rate.
The FDA encouraged Neoprobe to request a series of pre-NDA meetings in coming months to review the components of the application prior to its submission. Neoprobe officials told the FDA they plan to submit the application after successful meetings with the regulator, according to a company release.
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“We are very pleased with our recent discussions with the FDA review team regarding the NEO3-05 Phase 3 clinical results,” David Bupp, Neoprobe’s president and chief executive, in the statement. “The results from this meeting have clearly confirmed our pathway for the submission of a NDA approximating our previously disclosed target time line.”
