July 12, 2021

The U.S. FDA has approved a new indication for Janssen’s Darzalex Faspro® (daratumumab/ hyaluronidase-fihj) to be used in combination with pomalidomide and dexamethasone (Pd) to treat multiple myeloma in adults who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor. This is the sixth FDA-approved multiple myeloma indication for the drug.

Multiple myeloma is a cancer of blood plasma cells. Healthy plasma cells are a type of white blood cell responsible for producing antibodies to fight infection. Multiple myeloma cells are plasma cells that have become cancerous and produce abnormal proteins. They can crowd out healthy cells in the bone marrow and reduce the body’s ability to fight infection. In addition, the abnormal proteins they produce can damage the body’s organs. The overall five-year survival rate for multiple myeloma is 54%.

In a clinical study, treatment with Darzalex Faspro plus Pd reduced the risk of disease progression or death by 37% compared to treatment with Pd alone. The median survival time for patients on Darzalex Faspro plus Pd was 12.4 months, compared to 6.9 months for patients treated with Pd only. In addition, response rates were higher for Darzalex Faspro and Pd versus Pd alone (69% vs. 46%). Patients on Darzalex Faspro and Pd were also more likely to have a complete response rate or better (25% vs. 4% on Pd) or a very good partial response (51% vs. 20% on Pd).

Recommended dosing for Darzalex Faspro is 1,800mg daratumumab and 30,000 units hyaluronidase given via subcutaneous injection into the abdomen over the course of 3-5 minutes. The drug should be administered by a healthcare provider and is given weekly for the first eight weeks, then every two weeks for the next eight doses, followed by once-monthly administration until disease progression occurs.

Darzalex Faspro first received FDA approval in 2020. In addition to its multiple myeloma indications, the drug holds accelerated approval to treat light chain amyloidosis in combination with bortezomib, cyclophosphamide, and dexamethasone in newly diagnosed patients.

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