Posted by Michael Wonder on 13 Jul 2019
Janssen submits application to U.S. FDA seeking approval of new Darzalex (daratumumab) subcutaneous formulation
12 July 2019 - Submission inclusive of data from Phase 3 COLUMBA study presented at ASCO.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a biologics license application to the U.S. FDA seeking approval of a new subcutaneous formulation of Darzalex (daratumumab), an intravenous treatment approved for certain patients with multiple myeloma.
The submission is supported by data from the Phase 3 COLUMBA (MMY3012) study first presented at the American Society of Clinical Oncology (ASCO) Annual Meeting that 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 2 PLEIADES (MMY2040) study are also included in the application. The subcutaneous formulation of Darzalex is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20) [Halozyme's ENHANZE drug delivery technology].
