Business
Halozyme Announces Janssen Receives U.S. FDA Approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in Combination with Carfilzomib and Dexamethasone for Patients with Multiple Myeloma After First or Subsequent Relapse
- Approval marks the ninth indication for DARZALEX FASPRO®, the only subcutaneous anti-CD38 monoclonal antibody approved across a range of standard treatment
About this update from Halozyme Therapeutics, Inc.
[{"type":"text","content":"- Approval marks the ninth indication for DARZALEX FASPRO®, the only subcutaneous anti-CD38 monoclonal antibody approved across a range of standard treatment regimens -\n\n\nSAN DIEGO, Dec. 1, 2021 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced 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. This approval follows Janssen's regulatory submission to the FDA in February 2021.\n\"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.\" \nThe 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. \nDARZALEX FASPRO® is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE® drug delivery technology.\nAbout Halozyme Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. Halozyme advises and supports its biopharmaceutical partners in key aspects of new drug development with the goal of improving patients' lives while helping its partners achieve global commercial success. As the innovators of the ENHANZE® technology, which can reduce hours-long treatments to a matter of minutes, Halozyme's commercially-validated solution has touched more than 500,000 patient lives via five commercialized products across more than 100 global markets. Halozyme and its world-class partners are currently advancing multiple therapeutic programs intended to deliver innovative therapies, with the potential to improve the lives o...