Janssen Announces FDA Approval of DARZALEX FASPRO (daratumumab and hyaluronidase-fihj)

Janssen Pharmaceutical

HORSHAM, PA — The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with pomalidomide and dexamethasone (Pd) for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor. The approval follows the regulatory submission to the FDA in November 2020 and marks the sixth indication for DARZALEX FASPRO® in the treatment of multiple myeloma. Findings from the Phase 3 APOLLO study were presented at the 2020 American Society of Hematology (ASH) Annual Meeting and were recently published in The Lancet Oncology.

“Clinical studies including APOLLO have continued to show the ability of daratumumab-based combination treatment regimens to significantly reduce the risk of progression in patients with multiple myeloma,” said Meletios A. Dimopoulos, M.D.*, Professor and Chairman of the Department of Clinical Therapeutics at the National and Kapodistrian University of Athens School of Medicine, Athens, Greece, and principal investigator. “With this approval, we are now able to combine pomalidomide and dexamethasone with a daratumumab subcutaneous option that can be administered in minutes rather than the hours needed for intravenous administration.”

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The APOLLO study met its primary endpoint of improved progression-free survival (PFS), demonstrating that DARZALEX FASPRO®-Pd significantly reduced the risk of progression or death by 37 percent, compared to Pd alone (hazard ratio, 0.63; 95 percent confidence interval [CI], 0.47-0.85; P=0.0018).1 The median PFS for the DARZALEX FASPRO®-Pd arm vs. Pd arm was 12.4 vs. 6.9 months, respectively.1 Study findings additionally showed the rate of overall response to be significantly higher in DARZALEX FASPRO®-Pd compared to Pd alone (69 percent vs. 46 percent), as well as rates of complete response or better (25 percent vs. 4 percent) and very good partial response or better (51 percent vs. 20 percent).1 Additionally, more patients treated with DARZALEX FASPRO®-Pd showed a negative status for minimal residual disease than patients receiving Pd alone (9 percent vs. 2 percent).1

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Permanent treatment discontinuation due to an adverse reaction occurred in 2 percent of patients who received DARZALEX FASPRO®-Pd. No adverse reactions resulting in permanent discontinuation occurred in more than 1 patient. The most common adverse reactions (≥20 percent) were fatigue, pneumonia, upper respiratory tract infection, and diarrhea. Serious adverse reactions occurred in 50 percent of patients who received DARZALEX FASPRO®-Pd. The most frequent serious adverse reactions in >5 percent of patients who received DARZALEX FASPRO®-Pd were pneumonia (15 percent) and lower respiratory tract infection (12 percent). Fatal adverse reactions occurred in 7 percent of patients who received DARZALEX FASPRO®-Pd.

“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, M.D., Vice President, Late Development and Global Medical Affairs, Janssen Research & Development, LLC. “[The] 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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About the APOLLO Study1
APOLLO (NCT01960348) is an ongoing multicenter, Phase 3, randomized, open-label study comparing DARZALEX FASPRO®/ daratumumab SC in combination with pomalidomide and low-dose dexamethasone with pomalidomide and low-dose dexamethasone alone in patients with relapsed or refractory multiple myeloma who have received at least one prior treatment regimen, have received both lenalidomide and a proteasome inhibitor, and have demonstrated disease progression. The study enrolled 304 participants. The primary endpoint is PFS. Secondary endpoints include rates of overall response (ORR), very good partial response (VGPR) or better, complete response (CR) or better, and duration of response.

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