– Approval marks the ninth indication for DARZALEX FASPRO®, the only subcutaneous anti-CD38 monoclonal antibody approved across a range of standard treatment regimens –

SAN DIEGO, CA, USA I December 1, 2021 I 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.

“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.

About 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 of patients around the globe. Halozyme’s proprietary enzyme rHuPH20 forms the basis of the ENHANZE® technology and is used to facilitate the delivery of injected drugs and fluids, potentially reducing the treatment burden of other drugs to patients. Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including AbbVie, Alexion, argenx, Baxalta, Bristol-Myers Squibb, Horizon, Lilly, Pfizer, Roche and ViiV Healthcare. Halozyme derives revenues from these collaborations in the form of milestones and royalties as the Company’s partners make progress developing and commercializing their products being developed with ENHANZE®. Halozyme is headquartered in San Diego. For more information visit Halozyme.com and connect with us on LinkedIn and Twitter.

SOURCE: Halozyme Therapeutics