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Halozyme Announces Janssen Receives Two Positive CHMP Opinions for DARZALEX® (daratumumab) Subcutaneous Formulation Utilizing ENHANZE®
- For Use of Subcutaneous Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (D-VCd) in Newly Diagnosed Adult Patients with
About this update from Halozyme Therapeutics, Inc.
[{"type":"text","content":"- For Use of Subcutaneous Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (D-VCd) in Newly Diagnosed Adult Patients with Systemic Light Chain (AL) Amyloidosis -\n - For Use of Subcutaneous Daratumumab in Combination with Pomalidomide and Dexamethasone (D-Pd) in Adult Patients with Relapsed or Refractory Multiple Myeloma -\n\n\n SAN DIEGO, May 21, 2021 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that Janssen Pharmaceutica N.V. (Janssen) received two positive opinions from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending to broaden the existing marketing authorization for the DARZALEX® (daratumumab) subcutaneous (SC) formulation, which uses ENHANZE® technology, in two new indications. One recommendation is for the use in combination with cyclophosphamide, bortezomib and dexamethasone (D-VCd), for the treatment of adult patients with newly diagnosed systemic light chain (AL) amyloidosis. The second recommendation is for the use of daratumumab SC in combination with pomalidomide and dexamethasone (D-Pd) for the treatment of adult patients with multiple myeloma 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. These two positive opinions will next be reviewed by the European Commission (EC), which has the authority to grant final approval of the indications.\n\"Janssen's obtaining positive CHMP opinions is an important step forward in the EU and we are delighted subcutaneous DARZALEX® may soon be available in these important new indications,\" said Helen Torley, president and chief executive officer at Halozyme. \"This would be the first approval in Europe for the treatment of AL amyloidosis and also introduces a new treatment option for certain patients with multiple myeloma.\" \nThe Positive CHMP Opinion for the AL amyloidosis indication is supported by data from Janssen's Phase 3 ANDROMEDA study.1 Janssen reported that the study met the primary endpoint of percentage of patients with hematologic complete response. \nThe Positive CHMP Opinion for daratumumab SC in comb...