Janssen Receives FDA Approval of DARZALEX FASPRO with ENHANZE for Multiple Myeloma

Halozyme Therapeutics announced its collaborator Janssen Biotech has received approval from the U.S. Food and Drug Administration (FDA) for DARZALEX FASPRO™ (daratumumab hyaluronidase human- fihj). DARZALEX FASPRO™ is approved in four regimens across five indications in multiple myeloma patients, including newly diagnosed, transplant-ineligible patients as well as relapsed or refractory patients.

"We are delighted that DARZALEX FASPRO™ has been approved in the U.S. making it possible for patients diagnosed with multiple myeloma to receive daratumumab (DARZALEX®) treatment in 3-5 minutes with a subcutaneous injection rather than through a multi-hour intravenous infusion. This can reduce the treatment burden for patients, significantly shortening the time required in the physician clinic, hospital in-patient and out-patient treatment centers," said Dr. Helen Torley, president and chief executive officer. "We are also pleased with the breadth of indications granted to DARZALEX FASPRO™, which includes the majority of the indications granted for the IV DARZALEX® formulation."

DARZALEX FASPRO™ is approved for the treatment of adult patients with multiple myeloma: in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant (ASCT); in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for ASCT and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy; in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.

Halozyme's proprietary ENHANZE® drug-delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. ENHANZE® may also benefit subcutaneous biologics by reducing the need for multiple injections. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.

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