Halozyme Therapeutics Inc. (NASDAQ: HALO) has announced that the US FDA has granted Janssen Biotech Inc. approval for DARZALEK FASPRO in combination with kyprolis (carfilzomib) in treating adult patients having refractory/relapsed multiple myeloma that has received three previous lines of therapy. The approval comes at the back of a regulatory submission to the FDA in February this year.
Janssen receives approval for DARXALEX FASPRO for the ninth indication
CEO and President of Halozyme Helen Torley said, “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. 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.”
Based on Janssen’s PLEIADES study results, the FDA approved DARZALEX FASPRO. The PLEIADES study met its overall response rate primary endpoint. Please see Janssen’s press statement from today for more details on the PLEIADES research and its findings. DARZALEX FASPRO is designed with Halozyme’s ENHANCE medication delivery technology and recombinant human hyaluronidase PH20 (rHuPH20).
ENHANCE Platform shortens hours-long treatment
The company’s commercially certified ENHANZE® technology can potentially shorten hours-long treatments to a few minutes. The technology has touched over 500,000 patient lives through five commercialized products in more than 100 global markets. Also, the company and its leading partners are now advancing several therapeutic programs to develop novel therapeutics that can enhance the lives of patients across the world. The ENHANZE® technology is based on Halozyme’s proprietary enzyme rHuPH20, which is utilized to facilitate the delivery of injectable medications and fluids, possibly lessening the treatment load of other treatments on patients.
Leading pharmaceutical and biotechnology firms have licensed Halozyme’s ENHANZE® technology, including Alexion, AbbVie, Bristol-Myers Squibb, Horizon, Pfizer, Lilly, and ViiV Healthcare. As Halozyme’s partners make progress in developing and commercializing their ENHANZE®-based solutions, the company earns money from these collaborations in the form of milestones and royalties.
