Darzalex receives breakthrough designation in multiple myeloma from FDA
pharmafile | July 26, 2016 | News story | Manufacturing and Production, Research and Development | FDA, Genmab, Janssen, darzalex, multiple myeloma
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Darzalex (daratumumab) in combination with standard of care regimens for the treatment of patients with multiple myeloma who have received at least one prior therapy.
Multiple myeloma is a cancer arising from plasma cells which are made in the bone marrow. These plasma can become abnormal, multiply uncontrollably and creates an antibody called paraprotein which, in turn, leads to the often fatal cancer. It represents around 2% of all cancers diagnosed, with 5,500 people diagnosed each year in the UK, alone.
The drug, which binds with high affinity to the CD38 molecule which is highly expressed on the surface of multiple myeloma cells, is being developed by Janssen who agreed an exclusive deal to license Darzalex with Genmab.
The FDA breakthrough designation is a program which expedites the development and review of drugs when early data suggests that the treatment may provide substantial improvements on existing therapy. It has already been approved as a monotherapy in the US, and the EU.
With this latest designation, Darzalex will be fast-tracked in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of multiple myeloma patients who have had at least one prior therapy.
The designation is based on positive Phase III data showing the drug’s efficacy in combination with these standard of care treatments, versus these established regimens alone.
Jan van de Winkel, chief executive officer of Genmab, says: “This is the second time daratumumab has earned the distinction of a breakthrough therapy designation. We are pleased that the FDA continues to recognise the potential of daratumumab to help patients with multiple myeloma. We continue to work with our strategic partner Janssen and the regulatory authorities to advance daratumumab to bring this treatment to more patients suffering from multiple myeloma as quickly as possible.”
Sean Murray
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