On December 1, 2021 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported Janssen Biotech, Inc. (Janssen) received U.S. Food and Drug Administration (FDA) approval of DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in combination with Kyprolis (carfilzomib) and dexamethasone (Kd) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy (Press release, Halozyme, DEC 1, 2021, View Source [SID1234596366]). This approval follows Janssen’s regulatory submission to the FDA in February 2021.

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"We are pleased that Janssen received U.S. FDA approval for the ninth indication for DARZALEX FASPRO in multiple myeloma, this time in combination with Kyprolis (carfilzomib) and dexamethasone," said Helen Torley, president and chief executive officer at Halozyme. "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."

The FDA approval for DARZALEX FASPRO is based on data from Janssen’s PLEIADES Study, which met its primary endpoint of overall response rate. For more information about the PLEIADES study and its findings, please view Janssen’s press release issued today.

DARZALEX FASPRO is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE drug delivery technology.