The U.S. Food and Drug Admnistration will give priority review to Darzalex (daratumumab) as an add-on to standard treatments for multiple myeloma patients who cannot have a stem cell transplant.
Janssen Biotech filed the supplemental Biologics License Application for Darzalex to be used in combination with either Velcade (bortezomib), Alkeran (melphalan), or prednisone (VMP).
Priority review will shorten the time it takes the agency to make a decision from 10 to six months. This means a decision is expected by May 2018.
In 2012, Darzalex’s maker, Genmab, granted Janssen Biotech the exclusive worldwide rights to develop, manufacture and commercialize Darzalex.
The new application is supported by the results of the Phase 3 ALCYONE clinical trial (NCT02195479), which randomized patients to receive VMP, with or without Darzalex, for nine cycles.
Afterward, patients in the Darzalex arm received it as a maintenance therapy once every 28 days until their disease progressed.
The trial’s primary goal was to determine if Darzalex could delay the progression of myeloma when given as a first treatment to patients unable to have a stem cell transplant. Secondary goals included seeing how Darzalex would affect patients’ overall response rate, complete response rate, time to disease progression, and time to next treatment.
At 18 months, 71.6 percent of patients in the Darzalex arm had not died or had their disease progress, compared with only 50.2 percent in the control arm. This translated into a 50 percent reduction in the risk of disease progression or death when Darzalex was used to treat these patients.
Similarly, 91 percent of patients on Darzalex responded to the treatment, compared with 73.9 percent in the control group. Complete responses were also better with Darzalex – 42.6 percent versus 24.4 percent.
The results were published in December 2017 in The New England Journal of Medicine. The study is titled “Daratumumab plus Bortezomib, Melphalan, and Prednisone for Untreated Myeloma.”
“The granting of priority review to the submission of daratumumab in front-line multiple myeloma is an important step forward towards potentially bringing this product to an even larger number of patients in need,” Jan van de Winkel, Genmab’s chief executive officer, said in a press release.
Darzalex was first approved for multiple myeloma in November 2015 as a single therapy for patients who had received at least three previous lines of treatment. Additional approvals were granted in November 2016 and June 2017 for Darzalex as an add-on to different treatment regimens.