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Daratumumab and Hyaluronidase-fihj Approved by FDA for Multiple Myeloma

By: Jocelyn Solis-Moreira, MS
Posted: Wednesday, May 6, 2020

On May 1, the U.S. Food and Drug Administration (FDA) granted approval for daratumumab and hyaluronidase-fijh (Darzalex Faspro) for adult patients with newly diagnosed or relapsed or refractory multiple myeloma. The recommended dose is 1,800 mg of daratumumab and 30,000 U of hyaluronidase administered subcutaneously into the abdomen for approximately 3 to 5 minutes. Daratumumab and hyaluronidase-fihj monotherapy was also approved for several indications that IV daratumumab had previously received. Daratumumab is a CD38-directed antibody designed to inhibit tumor cell growth.

The FDA approval was based on the phase III COLUMBA and phase II PLEIADES trial results. The open-label, noninferiority COLUMBA trial randomly assigned 263 patients to receive daratumumab and hyaluronidase-fijh and 263 patients to receive daratumumab IV. The overall response rate was noninferior in patients given the combination therapy compared with daratumumab alone (41% vs. 37%; respectively; 95% confidence Interval [CI] = 0.89–1.37). In addition, the pharmacokinetic endpoint was met, as the geometric mean ratio for maximum Ctrough was 108% in the subcutaneous versus the IV dose (90% CI = 96%–122%).

In the open-label, multicohort PLEIADES trial, the study enrolled patients who were newly diagnosed with multiple myeloma and were ineligible for transplantation. In a single-arm cohort, the overall response rate was 88.1% (95% CI = 77.8%–94.7%) in patients who received the combination therapy with bortezomib/melphalan/prednisone. Moreover, the overall response rate was 90.8% in patients who had received at least one prior line of therapy and were administered daratumumab and hyaluronidase-fihj in combination with lenalidomide and dexamethasone.

The most common adverse reaction observed in more than 20% of patients who received daratumumab and hyaluronidase-fihj was upper respiratory tract infection. Common hematologic laboratory abnormalities observed in more than 40% of patients who received the combination therapy were decreases in leukocytes, lymphocytes, neutrophils, platelets, and hemoglobin levels.

For more prescribing information, visit accessdata.fda.gov.



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