Japanese Regulator Approves Darzalex Combo for Relapsed or Refractory Multiple Myeloma

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by Alice Melão |

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Japan approves Darzalex

The Japanese Ministry of Health, Labor, and Welfare has approved Darzalex (daratumumab) in combination with either Revlimid (lenalidomide) and dexamethasone, or Velcade (bortezomib) and dexamethasone, for the treatment of adults with relapsed or refractory multiple myeloma.

“Multiple myeloma is one of the most common forms of blood cancer in Japan and we are very pleased that Darzalex will soon also become available for Japanese multiple myeloma patients who have failed other treatments,” Jan van de Winkel, PhD, chief executive officer of Genmab, said in a press release.

Developed by Genmab in collaboration with Janssen Biotech, Darzalex is an antibody targeting the CD38 molecule, which is overexpressed by myeloma cells. After binding to CD38, the drug activates multiple immune-mediated mechanisms that directly promote cancer cell death.

Darzalex was the first antibody to receive U.S. approval for the treatment of multiple myeloma patients. It is now approved both as a monotherapy and in combination with other myeloma therapies.

The U.S. Food and Drug Administration (FDA) and the European Union (EU) approved these Darzalex combo therapies for relapsed or refractory myeloma patients in November 2016 and May 2016.

Like the U.S. and European approvals, the Japanese decision was based on clinical data from the Phase 3 POLLUX (NCT02076009) and CASTOR (NCT02136134) studies.

The findings, published in The New England Journal of Medicine, showed that the combination of Darzalex plus Revlimid and dexamethasone, and Darzalex plus Velcade and dexamethsone, reduced the risk of disease progression or death by 63% and 61%, respectively.

The safety profile of the Darzalex combo in these trials was consistent with safety data from trials testing the drug on its own. The most common adverse events were low levels of immune cells called neutrophils, platelets, and red blood cells. Infusion-related complications were also reported during the trials.

The two studies were titled, “Daratumumab, Lenalidomide, and Dexamethasone for Multiple Myeloma,” and “Daratumumab, Bortezomib, and Dexamethasone for Multiple Myeloma.”

The regulatory decision was also supported by several other myeloma studies, including two Phase 1 safety studies (NCT02116569 and NCT02497378) conducted in Japan.

Genmab is evaluating Darzalex in additional diseases, including smoldering myeloma, natural killer T-cell lymphoma, amyloidosis, myelodysplastic syndromes, and solid tumors.