Neoprobe readies for cancer new drug application

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).

TheDublin, Ohio,developer of oncology, and surgical diagnostic and treatment products completed its Phase 3 trial of Lymphoseek in early December. In the trial, Lymphoseek was97 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 incoming months to review the components of the applicationprior to itssubmission. Neoprobe officials toldtheFDA theyplan to submit the application aftersuccessful meetings with the regulator, according to a company release.

“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.”