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NEW INDICATIONS

FDA Approves Darzalex Faspro plus Pomalyst and Dexamethasone for Multiple Myeloma

Web Exclusives - FDA Updates

On July 9, 2021, the FDA accelerated the approval of a new indication for daratumumab and hyaluronidase-fihj (Darzalex Faspro; Janssen Biotech), in combination with pomalidomide (Pomalyst; Bristol Myers Squibb) and dexamethasone, for the treatment of adults with multiple myeloma who have received at least 1 previous line of therapy, including lenalidomide (Revlimid) or a proteasome inhibitor.

Daratumumab and hyaluronidase, as well as pomalidomide, are each already approved for the treatment of patients with multiple myeloma, alone or in combination with other drugs.

This new indication was based on the results of the APOLLO study, an open-label, active-controlled clinical trial of 304 patients who were randomized in a 1:1 ratio to daratumumab and hyaluronidase plus pomalidomide and dexamethasone or to pomalidomide and dexamethasone alone.

The primary end point was progression-free survival (PFS). The median PFS was 12.4 months in the daratumumab and hyaluronidase plus pomalidomide and dexamethasone arm versus 6.9 months with pomalidomide and dexamethasone alone (hazard ratio, 0.63; 95% confidence interval, 0.47-0.85; P = .0018), a 37% risk reduction of disease progression or death with the 3-drug versus the 2-drug combination.

The most common (≥20%) adverse reactions with the 3-drug combination were fatigue, pneumonia, upper respiratory tract infection, and diarrhea.

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