Janssen's Subcutaneous Darzalex Combo Wins FDA Approval For Pretreated Multiple Myeloma

Johnson & Johnson's JNJ Janssen Biotech Inc has received FDA approval for Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with Amgen Inc's AMGN Kyprolis (carfilzomib) and dexamethasone (Kd) for multiple myeloma.

• The combo has been approved for treating adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy.
• The FDA approval for Darzalex Faspro is based on Janssen's PLEIADES Study data, which met its primary endpoint, demonstrating an overall response rate of 84.8%. 
• Darzalex Faspro is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme Therapeutics Inc's HALO Enhanze drug delivery technology.
• "With its three-to-five-minute subcutaneous administration, Darzalex Faspro is now a treatment option for a broader range of patients suffering from multiple myeloma," said Helen Torley, president & CEO at Halozyme. 
• See here Benzinga's Full FDA Calendar.
• Price Action: JNJ shares are up 0.43% at $158.76 during the premarket session on the last check Thursday.