Janssen Biotech’s drug against multiple myeloma Darzalex, has gotten the U.S. Food and Drug Administration (FDA) approval, in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.
Multiple myeloma is an incurable blood cancer that occurs when malignant plasma cells grow uncontrollably in the bone marrow.
According to Janssen, clinical studies have shown that Darzalex, in combination with an immunomodulatory agent lenalidomide, and dexamethasone, reduced the risk of disease progression or death by 63 percent, compared to lenalidomide and dexamethasone alone, in patients with multiple myeloma who received a median of one prior therapy.
In combination with bortezomib, Darzalex reduced the risk of disease progression or death by 61 percent, compared to bortezomib and dexamethasone alone, in patients with multiple myeloma who received a median of two prior lines of therapy.
The approval, supported by data from two Phase 3 studies, comes three months after a supplemental Biologics License Application (sBLA) was submitted to the FDA in August 2016.4 Darzalex received Breakthrough Therapy Designation from the FDA for this indication in July 2016.5
“While tremendous progress in the treatment of multiple myeloma has been made in the past decade, patients and their physicians continue to need new treatment options,” said Meletios A. Dimopoulos, M.D., Department of Clinical Therapeutics, National and Kapodistrian University of Athens School of Medicine, Alexandra General Hospital, Athens, Greece, a Darzalex clinical trial investigator.
“With Darzalex, we have a potential new backbone therapy, which has shown pronounced efficacy as either a single agent or in combination with standard of care regimens. The addition of Darzalex also significantly improved progression-free survival in combination with two of the most widely used treatment classes, making it a versatile option for patients who have received at least one prior therapy,” Dimopoulos said.
“The approval of daratumumab provides multiple myeloma patients with another versatile treatment option to help address their urgent medical needs,” said Paul Giusti, President and Chief Executive Officer of the Multiple Myeloma Research Foundation (MMRF). “At the MMRF, we are excited by the groundbreaking work being done to bring effective, new treatments to patients.”
Darzalex is the first CD38-directed cytolytic antibody approved anywhere in the world.6 It was first approved by the FDA in November 2015 as a monotherapy treatment for patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double refractory to a PI and immunomodulatory agent.
Peter F. Lebowitz, M.D., Ph.D., Global Oncology Head, Janssen Research & Development, said: “We are only starting to uncover the full potential of this compound, and we remain committed to the continued study of daratumumab to more fully understand its utility for patients with multiple myeloma and other cancer types.”