J&J submits supplemental BLA for Darzalex Faspro to FDA

Johnson & Johnson (NYSE:JNJ) has submitted a supplemental Biologics License Application for its drug Darzalex Faspro in combination with three other medications for the treatment of newly diagnosed multiple myeloma patients.

More specifically, J&J is seeking to have the product approved in combination with bortezomib, lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible autologous stem cell transplant or for whom the procedure has been deferred, according to a statement.

J&J licensed daratumumab, a key component of Darzalex Faspro, from Genmab (GMAB) in 2012. Darzalex Faspro is formulated using Halozyme’s (HALO) drug delivery technology, Enhanze.

Darzalex Faspro is FDA approved for nine indications in multiple myeloma. The product was first approved in 2020.