Janssen Gets Two Positive CHMP Opinions For Darzalex Subcutaneous Formulation Utilizing Enhanze
NEW BRUNSWICK (dpa-AFX) - 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-refract
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New $160,000 drug for multiple myeloma blood cancer to be added to PBS at a cost to patients of $480
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MonMonday 28
DecDecember 2020 at 3:35am
Professor Miles Prince said the drug could allow patients to go years without needing further treatment.
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More than 1,000 patients with an incurable type of blood cancer are expected to benefit from a completely new treatment that will be subsidised by the Federal Government in the new year.
Key points:
Multiple myeloma is a type of blood cancer that causes about 1,000 deaths in Australia each year
The drug Darzalex works by binding to the cancerous cells and allowing them to be destroyed