The US Food and Drug Administration (FDA) has approved Janssen Pharmaceutical ‘s Darzalex (daratumumab) to treat patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
Darzalex is the first monoclonal antibody approved for this indication, an incurable blood cancer that occurs when malignant plasma cells grow uncontrollably in the bone marrow.
Clinical trial of Darzalex in combination with Velcade (bortezomib), a proteasome inhibitor; melphalan, an alkylating agent; and prednisone (VMP) showed that it reduced the risk of disease progression or death by 50% compared with VMP alone.
Janssen research & development oncology global therapeutic area head Peter Lebowitz said: “We are grateful to the patients and physicians who participated in the clinical programme that enabled today’s important approval of Darzalex combination therapy as a treatment option for newly diagnosed patients with multiple myeloma who are transplant ineligible.
“Darzalex has redefined how we approach the treatment of multiple myeloma, and we continue to evaluate its potential in combination with other regimens, with the aim of arresting the disease at its earliest stages.”
The approval of the therapy in combination with VMP is supported by data from a randomised, open-label, multi-centre Phase III study.
Treatment using the combination has improved overall response rates. Patients achieved a more than three-fold increase in the minimal residual disease negativity rate compared with those who received VMP alone.
Darzalex is a CD38-directed antibody and this latest FDA approval marks its fifth indication.
Initially, it was approved by the FDA in November 2015 as a monotherapy for patients with multiple myeloma. Additional approvals were secured in November 2016 in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone.