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FDA grants priority review to frontline Darzalex for multiple myeloma
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The FDA granted priority review to daratumumab in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant, according to a manufacturer-issued press release.
Daratumumab (Darzalex; Janssen, Genmab) — a monoclonal antibody — is indicated in combination therapy for the treatment of patients with multiple myeloma who have received at least two prior therapies or as a monotherapy for patients who have received at least three prior therapies.
The FDA based the priority review designation on the results of the phase 3 ALCYONE study, which evaluated the addition of daratumumab to bortezomib (Velcade, Millennium/Takeda), melphalan and prednisone among 706 patients aged 65 years or older (median age, 71 years; range, 40-93; 29.9% aged 75 years or older) with multiple myeloma. Researchers randomly assigned patients to receive nine cycles bortezomib, melphalan and prednisone alone or with daratumumab.
Patients assigned daratumumab exhibited a 50% reduced risk for progression or death (median PFS, not reached vs. 18.1 months; HR = 0.5; 95% CI, 0.38-0.65).
Researchers reported higher rates of 12-month PFS (87% vs. 76%) and 18-month PFS (72% vs. 50%) in the daratumumab group.
As HemOnc Today previously reported, results of this study were presented at ASH Annual Meeting and Exposition and simultaneously published in The New England Journal of Medicine.
“The granting of priority review to the submission of daratumumab in frontline multiple myeloma is an important step forward toward potentially bringing this product to an even larger number of patients in need,” Jan van de Winkel, PhD, CEO of Genmab, said in the release.
The FDA assigned an action date of May 21, 2018 for this review.