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FDA Approves Daratumumab and Hyaluronidase-Fihj With Chemo and Steroid for Multiple Myeloma

Multiple myeloma.

The FDA has granted approval to daratumumab and hyaluronidase-fihj (Darzalex Faspro®, Janssen Biotech, Inc.) in combination with pomalidomide and dexamethasone for patients with multiple myeloma who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor.

"In a phase 1b study, intravenous daratumumab plus pomalidomide and dexamethasone induced a very good partial response," wrote Meletios A. Dimopoulos, MD, Professor and Chairman of the Department of Clinical Therapeutics at the National and Kapodistrian University of Athens School of Medicine in Greece, and colleagues, in their publication of results of the phase 3 APOLLO trial (NCT03180736), on which the approval was based. "We aimed to evaluate whether daratumumab plus pomalidomide and dexamethasone would improve progression-free survival versus pomalidomide and dexamethasone alone in patients with previously treated multiple myeloma."

This ongoing, open-label, randomized trial enrolled 304 patients who had relapsed or refractory multiple myeloma with measurable disease. Eligible patients had an Eastern Cooperative Oncology Group performance status of 0-2; had received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor; had a partial response or better to one or more previous lines of antimyeloma therapy; and were refractory to lenalidomide if only one previous line of therapy was received. Patients were randomized 1:1 to receive 1,800 mg daratumumab and 30,000 units hyaluronidase-fihj administered subcutaneously once weekly from Weeks 1 to 8, once every 2 weeks from Weeks 9 to 24, and once every 4 weeks starting on Week 25 until disease progression or unacceptable toxicity, in combination with 4 mg pomalidomide, once daily on Days 1-21 of each 28-day cycle and 40 mg dexamethasone per week (though reduced to 20 mg per week for patients over 75 years old), versus receiving pomalidomide and dexamethasone alone. The primary end point was progression-free survival.

At a median follow-up of 16.9 months, the daratumumab and hyaluronidase-fihj plus pomalidomide and dexamethasone group had a median progression-free survival of 12.4 months, compared with 6.9 months in the pomalidomide and dexamethasone group, constituting a 37% reduction in the risk of disease progression or death.

The most common adverse events occurring in at least 20% of patients receiving the daratumumab combination were fatigue, pneumonia, upper respiratory tract infection, and diarrhea.

"Among patients with relapsed or refractory multiple myeloma, daratumumab plus pomalidomide and dexamethasone reduced the risk of disease progression or death versus pomalidomide and dexamethasone alone," concluded Dr. Dimopoulous and colleagues in their June 2021 publication in The Lancet Oncology.

The recommended dose of daratumumab and hyaluronidase-fihj is 1,800 mg and 30,000 units, respectively, administered subcutaneously into the abdomen over approximately 3 to 5 minutes, according to the recommended schedule.

For More Information

Dimopoulos MA, Terpos E, Boccadoro M, et al (2021). Daratumumab plus pomalidomide and dexamethasone versus pomalidomide and dexamethasone alone in previously treated multiple myeloma (APOLLO): an open-label, randomised, phase 3 trial. Lancet Oncol, 22(6):801-812. DOI:10.1016/S1470-2045(21)00128-5

Clinicaltrials.gov (2021). Comparison of pomalidomide and dexamethasone with or without daratumumab in subjects with relapsed or refractory multiple myeloma previously treated with lenalidomide and a proteasome inhibitor daratumumab/pomalidomide/dexamethasone vs pomalidomide/dexamethasone (EMN14). NLM identifier: NCT03180736.

Darzalex Faspro® (daratumumab and hyaluronidase-fihj) prescribing information (2021). Janssen Biotech, Inc. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761145s007lbl.pdf

US Food & Drug Administration (2021). FDA approves daratumumab and hyaluronidase-fihj with pomalidomide and dexamethasone for multiple myeloma. Available at: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-pomalidomide-and-dexamethasone-multiple-myeloma

Image credit: Dr Erhabor Esaro. Licensed under CC BY-SA 3.0

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