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FDA Updates

Daratumumab Receives FDA Priority Review for Double-Refractory Myeloma

doi: 10.1097/01.COT.0000472799.80357.07
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The Food and Drug Administration has granted priority review designation to daratumumab for the treatment of patients with multiple myeloma who have received at least three different lines of therapy, including both a proteasome inhibitor and an immunomodulatory agent (iMiD), or who are double refractory to a proteasome inhibitor and an iMiD.

Daratumumab, which also received Breakthrough Therapy status for the same indication earlier this year (OT 5/25/15 issue), is an investigational human IgG1k monoclonal antibody that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells.

The drug induces rapid tumor cell death through several immune-mediated mechanisms, including complement-dependent cytotoxicity, antibody-dependent cellular phagocytosis, and antibody-dependent cellular cytotoxicity, as well as via induction of apoptosis.

The FDA's priority review designation shortens the time to complete a drug's review and aims to deliver a decision on marketing approval designation for drugs that may offer major advances in treatment or provide a treatment where no adequate therapy exists within six months under the Prescription Drug User Fee Act (PDUFA). The FDA action date for daratumumab for this indication is March 9.

Five Phase III Studies

Five Phase III clinical studies with daratumumab in relapsed and frontline settings are currently ongoing. And additional studies are ongoing or planned to assess its potential in other malignant and pre-malignant diseases on which CD38 is expressed, such as smoldering myeloma and non-Hodgkin lymphoma, according to a news release from Janssen Biotech, Inc., the drug company developing, manufacturing, and commercializing the drug in the U.S.

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