On September 27th Darzalex (daratumumab, Janssen) was granted approval in Japan to treat patients with Relapsed or Refractory Multiple Myeloma (RRMM). Approval was granted by the Ministry of Health, Labor and Welfare (MHLW) for use in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone. This will be welcome news in a country where MM is one of the most common forms of blood cancer.
Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule. In 2012, Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop, manufacture and commercialize daratumumab. Consequently, upon the first commercial sale in Japan, Genmab will receive milestone payments from Janssen of $25 million.
The decision was based on data from two pivotal phase III clinical trials – POLLUX and CASTOR. The results of these studies also influenced approval by the European Medicines Agency (EMA) in April this year, for the same indication. In the US, the approval is wider as daratumumab is also licensed for use in combination pomalidomide and dexamethasone (see previous MM Hub article) for patients that have received at least two prior therapies. In addition, both the US Food and Drug Administration (FDA) and EMA have approved its use as a monotherapy for RRMM patients whose prior therapy included a proteasome inhibitor (PI) and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.