Janssen Gets Two Positive CHMP Opinions For Darzalex Subcutaneous Formulation Utilizing Enhanze

(RTTNews) - Janssen Pharmaceutica received two positive opinions from the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency or EMA recommending to broaden the existing marketing authorization for the DARZALEX or daratumumab subcutaneous formulation, which uses ENHANZE technology, in two new indications, Halozyme Therapeutics Inc. (HALO) said in a statement.

One recommendation is for the use in combination with cyclophosphamide, bortezomib and dexamethasone, for the treatment of adult patients with newly diagnosed systemic light chain amyloidosis.

The second recommendation is for the use of daratumumab subcutaneous in combination with pomalidomide and dexamethasone 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.