FDA Approves Darzalex Faspro for Second-Line Treatment of Multiple Myeloma

Darzalex Faspro has received FDA approval for use in combination with pomalidomide and dexamethasone for patients with multiple myeloma who previously received one line of therapy.

The Food and Drug Administration (FDA) approved Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who previously received at least one prior therapy including lenalidomide and a proteasome inhibitor.

Darzalex Faspro is the only CD38-directed antibody approved by the FDA that can be subcutaneously administered for the treatment of patients with multiple myeloma, according to a news release from Janssen.

This FDA approval is based on findings from the phase 3 APOLLO study. In this study, Darzalex Faspro improved progression-free survival (the time after treatment that patients live with cancer without disease progression) by 37% compared with pomalidomide and dexamethasone alone (69% versus 46%). Darzalex Faspro also improved rates of complete response (disappearance of all signs of cancer from treatment) or better (25% versus 4%) and very good partial response (at least 90% reduction of serum monoclonal protein) or better (51% versus 20%). More patients assigned Darzalex Faspro had negative status for minimal residual disease compared with those assigned pomalidomide and dexamethasone alone (9% versus 2%).

“Clinical studies including APOLLO have continued to show the ability of (Darzalex Faspro) combination treatment regimens to significantly reduce the risk of progression in patients with multiple myeloma,” said Dr. Meletios A. Dimopoulos, professor and chairman of the department of clinical therapeutics at the National and Kapodistrian University of Athens School of Medicine in Greece and principal investigator of the APOLLO study, in the release. “With this approval, we are now able to combine pomalidomide and dexamethasone with a (Darzalex) subcutaneous option that can be administered in minutes rather than hours needed for intravenous administration.”

In the APOLLO study, 2% of patients assigned Darzalex Faspro permanently discontinued treatment from a side effect. The most common side effects that occurred in at least 20% of patients in the study included pneumonia, fatigue, diarrhea and upper respiratory infection. In addition, the most frequent serious side effects that occurred in at least 5% of patients in the study included lower respiratory tract infection (12%) and pneumonia (15%). Seven percent of patients treated with Darzalex Faspro in the study had fatal side effects.

“We are focused on the continued development of Darzalex Faspro and advancing this innovative therapy for patients who are in need of additional treatment options,” said Dr. Craig Tendler, vice president of late development and global medical affairs at Janssen Research & Development, in the release. “Today’s approval further distinguishes Darzalex Faspro in the treatment of multiple myeloma as the first and only subcutaneously administered anti-CD38 monoclonal antibody approved in combination with the widely used pomalidomide and dexamethasone regimen.”

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