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# Janssen BLA for Subcutaneous Form of Darzalex
- URL: https://www.fdaweb.com/janssen-bla-for-subcutaneous-form-of-darzalex/
- Published: 2019-07-12T12:00:00.000Z
- Updated: 2026-09-15T01:37:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144524

Janssen Pharmaceutical Companies has submitted a BLA for Darzalex (daratumumab) that seeks approval of a new subcutaneous formulation for treating certain patients with multiple myeloma. Currently, Darzalex is approved as an intravenous (IV) treatment. The submission is supported by data from the Phase 3 COLUMBA ([MMY3012](https://c212.net/c/link/?t=0&l=en&o=2522598-1&h=2080118065&u=https%3A%2F%2Fclinicaltrials.gov%2Fct2%2Fshow%2FNCT03277105%3Fterm%3DMMY3012%26rank%3D1&a=MMY3012&ref=fdaweb.com)) study that included a non-inferiority comparison to Darzalex IV administration for co-primary endpoints of overall response rate and maximum C-trough concentration. The subcutaneous formulation is co-formulated with recombinant human hyaluronidase PH20 (Halozyme’s ENHANZE drug delivery technology).