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Halozyme Announces Janssen Receives FDA Approval Of DARZALEX FASPRO® (Daratumumab And Hyaluronidase-fihj) As Treatment For Newly Diagnosed Patients With Light Chain (AL) Amyloidosis
- DARZALEX FASPRO® Utilizing ENHANZE® Represents First and Only Approved Treatment for Patients with Newly Diagnosed AL Amyloidosis - - Accelerated Approval
About this update from Halozyme Therapeutics, Inc.
[{"type":"text","content":"- DARZALEX FASPRO® Utilizing ENHANZE® Represents First and Only Approved Treatment for Patients with Newly Diagnosed AL Amyloidosis -\n - Accelerated Approval of DARZALEX FASPRO®-based Combination Regimen Supported by the PHASE 3 ANDROMEDA Study Demonstrating a Significantly Higher Hematologic Complete Response Rate in this Rare and Serious Blood Cell Disorder -\n\n\n SAN DIEGO, Jan. 15, 2021 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that Janssen Biotech, Inc. (Janssen) has received U.S. Food and Drug Administration (FDA) approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.1 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 (hemCR) 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 (AL) amyloidosis who have NYHA Class IIIB or Class IV cardiac disease or Mayo Stage IIIB outside of controlled clinical trials.\n\"We are delighted that DARZALEX FASPRO® utilizing our ENHANZE® technology has become the first and only FDA-approved treatment for newly diagnosed patients with AL amyloidosis,\" said Dr. Helen Torley, president and chief executive officer. \"AL amyloidosis represents an area of high unmet medical need.\" \nThe FDA approval is based on positive results from the Phase 3 ANDROMEDA study, which were recently presented at the American Society of Hematology (ASH) 2020 Annual Meeting. The study evaluated DARZALEX FASPRO® in combination with VCd, compared with VCd alone, a common treatment regimen offered to adult patients with newly diagnosed AL amyloidosis. 5 Patients receiving treatment with DARZALEX FASPRO® experienced a hemCR more than triple that of patients receiving VCd alone (42 percent for ...