Supplemental approval will expand PDT with Photofrin® treatments in specific lung and esophageal cancers
Concordia Healthcare Corp. (Concordia or the Company) (TSX:CXR) (OTCQX: CHEHF) announced today that its subsidiary Pinnacle Biologics, Inc. (Pinnacle), a biopharmaceutical research and development company specializing in rare diseases, was granted U.S. Food and Drug Administration (FDA) premarket supplemental approval (PMA) for its Optiguide® DCYL700 Fiber Optic Diffuser Series flexible fiber.
The Optiguide DCYL700 Fiber Optic Diffuser Series is a light delivery system used in Photodynamic Therapy (PDT) with PHOTOFRIN® (porfimer sodium) approved for use in the treatment of non-small cell lung cancer (NSCLC) and esophageal cancer. The system features a more flexible, narrower cylindrical diffuser design that may assist physicians by providing greater access to tumors located in the right upper lobe of the lung and by improving maneuverability in other potentially challenging anatomic areas of the bronchus.
According to thoracic surgeon Patrick Ross MD, Ph.D., chairman of the Pinnacle Scientific Advisory Board, “One of the key benefits of this new diffuser fiber is that it will offer improved compatibility with current endoscopic equipment. This may allow doctors to use bronchoscopes with smaller therapeutic channels and may allow easier access to NSCLC tumors located in the right upper lobe of the lung as well as other potentially challenging anatomic areas of the airways in the lungs.â€