FDA Expands Indication for Daratumumab Combination Treatment in Multiple Myeloma


Adults who have received at least one prior line of therapy may receive daratumumab and hyaluronidase-fihj combined with pomalidomide and dexamethasone.


The US Food and Drug Administration (FDA) approved daratumumab and hyaluronidase-fihj (DARZALEX FASPRO) in combination with pomalidomide and dexamethasone for adults with multiple myeloma who have received a prior line of therapy. 

This approval was granted to Janssen Biotech following the company's November 2020 regulatory submission to the FDA and expands upon the therapy's 5 previous indications.

"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 Craig Tendler, MD, Vice President of Late Development and Global Medical Affairs at Janssen Research & Development, in a statement.

"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,” he continued.

Supporting Data

The FDA’s decision was supported by evidence from the Phase III Apollo study, which met its primary endpoint of improved progression-free survival.

Daratumumab and hyaluronidase-fihj combination treatment was shown to reduce risk of disease progression or death by 37%—versus pomalidomide and dexamethasone alone (hazard ratio [HR], 0.63; 95% CI, 0.47-0.85; P = .0018).

Median progression-free survival for the daratumumab and hyaluronidase -fihj cohort compared to the pomalidomide and dexamethasone cohort were 12.4 months and 6.9 months, respectively.

Even more, the rate of overall response was higher in the former (69%) than the latter (46%) cohorts, as was rate of complete response or better (25% vs 4%) and very good partial response or better (51% vs 20%).

Investigators also reported that more patients treated with daratumumab and hyaluronidase-fihj plus pomalidomide and dexamethasone demonstrated a negative status for minimal residual disease (9%) than patients who received pomalidomide and dexamethasone alone (2%).

The most common serious adverse events associated with the newly approved combination therapy were pneumonia (15%) and lower respiratory tract infection (12%). Fatal adverse reactions occurred in 7% of patients who received the treatment.

The findings were recently presented at the 2020 American Society of Hematology (ASH) Annual Meeting.

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