The United States Food and Drug Administration (FDA) has received a Biologics License Application from The Janssen Pharmaceutical Companies of Johnson & Johnson for approval of a new subcutaneous formulation of DARZALEX, an intravenous treatment approved for certain patients with multiple myeloma, it was reported on Friday.
The submission is supported by data from the Phase three COLUMBA (MMY3012) study first revealed at the American Society of Clinical Oncology Annual Meeting, and which included a non-inferiority comparison to DARZALEX IV administration for co-primary endpoints of overall response rate and maximum Ctrough concentration.
Data from the Phase two PLEIADES (MMY2040) study are also included in the Biologics License Application. The subcutaneous formulation of DARZALEX is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20) [Halozyme's ENHANZE drug delivery technology].
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