Benzinga | Dec 2, 2021 06:52AM EST

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

Johnson & Johnson's (NYSE:JNJ) Janssen Biotech Inc has received FDA approval for Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with Amgen Inc's (NASDAQ: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 (NASDAQ: 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.