Janssen drug approved in combination against myeloma

The US FDA has approved Janssen’s Darzalex (daratumumab) in combination with other drugs, as second line therapy for patients multiple myeloma.

The Johnson & Johnson unit's drug was approved in combination with Celgene’s Revlimid (lenalidomide) and dexamethasone, or Janssen’s Velcade (bortezomib) and dexamethasone.

The market for multiple myeloma drugs is competitive, and there are cheaper chemotherapies already approved, along with branded drugs. But Darzalex, originally developed by Denmark's Genmab, represents a step forward compared with some existing treatments.

Clinical studies have shown that Darzalex, in combination with Revlimid, an immunomodulatory agent, and dexamethasone, reduced the risk of disease progression or death by 63%, compared to Revlimid and dexamethasone alone, in patients with multiple myeloma who received a median of one prior therapy.

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.

Multiple myeloma is an incurable blood cancer that occurs when malignant plasma cells grow uncontrollably in the bone marrow.