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.
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Posted In: BiotechNewsHealth CareFDAGeneralBriefsmultiple myeloma
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