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Halozyme Announces Janssen Receives European Marketing Authorizations for DARZALEX® (daratumumab) Subcutaneous Formulation for Newly Diagnosed Systemic Light-chain Amyloidosis and Pre-Treated Multiple Myeloma
- Janssen received European approval for DARZALEX® (daratumumab) subcutaneous formulation in combination with bortezomib, cyclophosphamide and dexamethasone
About this update from Halozyme Therapeutics, Inc.
[{"type":"text","content":"- Janssen received European approval for DARZALEX® (daratumumab) subcutaneous formulation in combination with bortezomib, cyclophosphamide and dexamethasone for the treatment of adult patients with newly diagnosed systemic light-chain (AL) amyloidosis, based on data from the Phase 3 ANDROMEDA study -\n - Janssen also received approval for DARZALEX® SC in combination with pomalidomide and dexamethasone for adult patients with relapsed or refractory multiple myeloma, based on the Phase 3 APOLLO study -\n\n\nSAN DIEGO, June 22, 2021 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that the European Commission (EC) has granted the Janssen Pharmaceutical Companies of Johnson & Johnson two marketing authorizations for the subcutaneous formulation of daratumumab, known as DARZALEX® SC in the European Union. The first authorization is for the use of DARZALEX® SC in combination with bortezomib, cyclophosphamide, and dexamethasone (VCd) for the treatment of adults with newly diagnosed systemic light-chain (AL) amyloidosis. The approval makes the DARZALEX® SC based regimen the first approved therapy for AL amyloidosis in Europe. The second authorization is for the use of DARZALEX® SC in combination with pomalidomide and dexamethasone (D-Pd) for the treatment of adults with multiple myeloma (MM) who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor, and have demonstrated disease progression on or after the last therapy.\n\"We are pleased that Janssen received European Commission marketing authorizations for these important new indications,\" said Helen Torley, president and chief executive officer at Halozyme. \"These authorizations will provide new treatment options for certain AL amyloidosis and multiple myeloma patients in Europe.\" \nDARZALEX® SC is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE® drug delivery technology.\nAbout HalozymeHalozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. Halozyme advises and supports its biopharmaceutical partners in key aspects of new drug development with ...