Approves Janssen Drug for Use in Bone Marrow Cancer
The US FDA has approved Janssen’s Darzalex in combination with other drugs, to be used as second line therapy for patients with bone marrow cancer.
The drug was approved in combination with Celgene’s Revlimid and dexamethasone, or Janssen’s Velcade and dexamethasone.
The market for multiple myeloma drugs is competitive, as there is a variety of more cost-effective chemotherapies already approved, along with branded drugs. However, Darzalex, originally developed by Denmark’s Genmab, is considered to be a breakthrough when compared to some existing treatments.
Data from clinical studies in patients with multiple myeloma who received a median of one prior therapy, showed that Darzalex, in combination with Revlimid – an immunomodulatory agent, and dexamethasone, reduced the risk of disease progression or death by 63%, when compared to Revlimid and dexamethasone alone.
In combination with Velcade, a proteasome inhibitor (PI), and dexamethasone, Darzalex reduced the risk of disease progression or death by 61%, compared to bortezomib and dexamethasone alone, in patients with multiple myeloma who received a median of two prior lines of therapy.
Janssen filed the drug with the FDA in August, after the regulator granted it Breakthrough Therapy designation in July, allowing faster review.
Darzalex is the first CD38-directed cytolytic antibody approved anywhere in the world. It was first approved by the FDA in November 2015 as a monotherapy 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.
Today’s approval is supported by data from two phase 3 studies.