On May 21, 2021 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported 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 (Press release, Halozyme, MAY 21, 2021, View Source [SID1234580434]). 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.
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"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."
The 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.
The Positive CHMP Opinion for daratumumab SC in combination with Pd in the treatment of relapsed or refractory multiple myeloma is supported by data from the Phase 3 APOLLO study conducted in collaboration with the European Myeloma Network. 2 Janssen reported that the study met its primary endpoint of improved progression-free survival (PFS).