The U.S. Food and Drug Administration said on Monday it had approved the use of Gamida Cell Ltd’s cell therapy for cutting the risk of infection in patients undergoing treatment for blood cancer, sending the company’s shares up 46%.
The approval allows the company to launch its first-ever commercial therapy under the brand name Omisirge for patients who are 12 years or older and are undergoing stem cell transplantation.
Prior to the process of the transplantation, patients often undergo radiation or chemotherapy, which can weaken their immune system and expose them to the risk of severe and sometimes deadly infections….