January 15, 2021

The U.S. FDA has approved a new indication for Darzalex Faspro® (daratumumab/ hyaluronidase-fihj), manufactured by Janssen Biotech. The drug is now indicated for use in combination with bortezomib, cyclophosphamide, and dexamethasone to treat newly diagnosed light chain (AL) amyloidosis.

AL is a rare condition in which light chains – which are proteins used by white blood cells to build antibodies – don’t fold into the proper shape. Instead, they become stuck together, creating amyloid fibrils that find their way into the body’s organs. In AL, these organs include the heart, kidney, stomach, liver, colon, nerves, and skin. This can lead a vast array of symptoms, depending on what parts of the body are affected. AL is a chronic disease, with a poor prognosis if it advances to the point that it affects the heart’s function.

In a clinical study, 78% of patients treated with Darzalex Faspro plus bortezomib, cyclophosphamide, and dexamethasone (D-VCd) achieved a very good partial response or better, compared to 49% of patients treated with bortezomib, cyclophosphamide, and dexamethasone (VCd). Nearly half (42%) of patients on D-VCd achieved a complete response, versus 13% on VCd.

Recommended dosing under the new indication is one vial administered once weekly for Weeks 1-8, then once every two weeks for Weeks 9-24, and every four weeks for Week 25 and onward. Treatment should continue until disease progression or unacceptable toxicity occur, or for up to a maximum of two years. The drug must be administered by a healthcare professional and is given as a subcutaneous injection over the course of three to five minutes.

Darzalex Faspro’s new indication was granted under accelerated approval. Continued approval for the indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

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