On April 30, 2020 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported that Janssen-Cilag International NV (Janssen) received a Committee for Medicinal Products for Human Use (CHMP) Positive Opinion from the European Medicines Agency (EMA) recommending approval of a DARZALEX (daratumumab) subcutaneous (SC) formulation for the treatment of adult patients with multiple myeloma in frontline and relapsed/refractory settings (Press release, Halozyme, APR 30, 2020, View Source [SID1234556847]). The CHMP’s Positive Opinion for daratumumab SC formulation applies to all current daratumumab indications including newly diagnosed and transplant-ineligible patients, as well as relapsed or refractory patients.
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The DARZALEX SC formulation utilizes Halozyme’s ENHANZE drug delivery technology and reduces the treatment time from several hours to approximately five minutes with comparable efficacy to intravenous DARZALEX and lower rates of infusion-related reactions.
"We are excited that a subcutaneous formulation of DARZALEX is one step closer to transforming the treatment experience for multiple myeloma patients and physicians in the European Union," said Dr. Helen Torley, president and chief executive officer. "Once available, multiple myeloma patients may benefit from a shorter infusion time when compared with a multi-hour intravenous infusion."
The CHMP opinion is supported by data from Janssen’s Phase 3 COLUMBA study, which investigated subcutaneously administered DARZALEX in comparison to intravenous DARZALEX in patients with relapsed and refractory multiple myeloma, and the Phase 2 PLEIADES study. In the COLUMBA study, subcutaneous DARZALEX, using ENHANZE drug delivery technology, was found to be non-inferior to intravenous DARZALEX with regard to the co-primary endpoints of overall response rate and maximum Ctrough concentration on day 1 of the third treatment cycle prior to dose.
About ENHANZE Technology
Halozyme’s proprietary ENHANZE drug delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. ENHANZE may also benefit subcutaneous biologics by reducing the need for multiple injections. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.