Blood Cancer Biologic Seeks FDA Approval

Janssen has submitted a Biologic License Application to the FDA seeking daratumumab's approval in multiple myeloma.

Janssen has submitted a Biologic License Application to the FDA seeking daratumumab’s approval in multiple myeloma.

The biologic is being investigated as a treatment for multiple myeloma patients who have received at least 3 prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or who are double refractory to a PI and an IMiD. It received Breakthrough Therapy Designation from the FDA for this patient population in May 2013.

"Despite therapeutic advances over the last 10 years, multiple myeloma remains an incurable disease, and many people eventually relapse or grow resistant to available therapies, which has underscored the need for newer medicines with novel mechanisms of action," stated Janssen global oncology head Peter Lebowitz. "We are proud of the Breakthrough Therapy Designation

daratumumab received and look forward to working in close collaboration with the FDA during its review."

Multiple myeloma is a blood cancer that currently has no cure. Patients who relapse during standard treatment with PIs or IMiDs have poor prognoses and few therapeutic options.

Daratumumab is an investigational human monoclonal antibody that binds to a transmembrane ectoenzyme on the surface of multiple myeloma cells, inducing rapid tumor cell death.

The drug’s rolling submission, which allows Janssen to submit portions of the regulatory application as they are completed, will be primarily supported by data from the phase 2 MMY2002 (SIRIUS) study announced last month, as well as findings from 4 other clinical studies.