Avelas Biosciences, Inc., pioneering the field of intraoperative fluorescent cancer imaging, today announced that the company has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for pegloprastide (AVB-620) for the intraoperative detection and visualization of positive margins during breast cancer surgery. Pegloprastide is designed to deliver a fluorescent marker to cancer cells to aid surgeons in identifying positive margins in real time during surgery. Positive margins can be a sign that cancer may be left behind, requiring a second surgery.
“We now have clarity on the development path to make fluorescence image-guided surgery the new standard of care for breast cancer lumpectomies,” said Jay Lichter, Ph.D., Chairman, President, and Chief Executive Officer of Avelas. “Pegloprastide has the potential to greatly reduce the number of repeat surgeries, potentially improving outcomes for hundreds of thousands of women and saving thousands of lives.”
The presence of positive margins is a significant challenge in breast-conserving surgery. Positive surgical margins occur when post-operative pathology indicates cancer cells are present at or very close to the edge of removed tissue, indicating that there may be residual cancer left behind after an operation. It is estimated that each year in the United States more than 260,000 women undergo a lumpectomy, of which one-third (more than 80,000) are repeat surgeries with the goal of achieving negative margins.1 Beyond that, of the estimated 90,000 women who choose a mastectomy, many choose it for fear of incomplete initial lumpectomy or due to an initial attempt at a lumpectomy that resulted in positive margins.1