FDA approves expanded use of Janssen’s Darzalex for multiple myeloma patients

Horsham, Pa.-based Janssen Biotech, a subsidiary of Johnson & Johnson, received Food and Drug Administration approval for an expanded use of its immunotherapy drug Darzalex.

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Darzalex can now be used in combination with two standard of care regimens —lenalidomide and dexamethasone, or bortezomib and dexamethasone — for the treatment of patients with multiple myeloma who have received at least one prior therapy, according to a company news release.

The FDA first approved the drug in November 2015 and the medication earned breakthrough therapy designation for the new indication in July 2016.

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