Radiopharmaceutical developer Navidea Biopharmaceuticals has announced positive results from a follow-up study of its Lymphoseek radiopharmaceutical.
The three-year, voluntary follow-up study was conducted in patients who participated in a phase III clinical trial of Lymphoseek, the company said. The study's primary objective was to determine the regional recurrence-free rate (RRFR) after sentinel lymph node biopsy with the radiopharmaceutical.
In patients who were confirmed to be node-negative after sentinel lymph node biopsy (n = 88; 49 breast cancer, 39 melanoma) the RRFR was 98.8% (100% in breast cancer, 97.4% in melanoma) and the disease-specific survival rate was 98.6% (97.8% in breast cancer, 100% in melanoma) at three years, the researchers found.
Lymphoseek is a receptor-targeted, small-molecule radiopharmaceutical approved by the U.S. Food and Drug Administration (FDA) for use in lymphatic mapping to assist in the localization of lymph nodes draining primary tumors in patients with breast cancer or melanoma.
