Halozyme says Janssen receives FDA approval of Darzalex Faspro

Halozyme Therapeutics (HALO) announced that Janssen Biotech, Inc. (JNJ) has received U.S. Food and Drug Administration approval of DARZALEX FASPRO in combination with bortezomib, cyclophosphamide and dexamethasone for the treatment of adult patients with newly diagnosed light chain amyloidosis. DARZALEX FASPRO is the first and only FDA-approved treatment for patients with this rare and serious blood disorder associated with the production of an abnormal protein which leads to the deterioration of vital organs, most notably the heart, kidneys and liver.1 This indication is approved under accelerated approval and is based on the combination's hematologic complete response rate measure. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. DARZALEX FASPRO is not indicated and is not recommended for the treatment of patients with light chain amyloidosis who have NYHA Class IIIB or Class IV cardiac disease or Mayo Stage IIIB outside of controlled clinical trials.