EU approval for Darzalex in frontline multiple myeloma

Johnson & Johnson’s (NYSE: JNJ) pharma unit Janssen has received European Commission (EC) marketing authorization for Darzalex (daratumumab) in combination with lenalidomide and dexamethasone (DRd) for the treatment of newly diagnosed multiple myeloma patients who are ineligible for autologous stem cell transplant (ASCT).

A similar label extension was granted for Darzalex by the US Food and Drug Administration in June this year.

“Despite recent therapeutic advances, relapse of multiple myeloma is considered to be almost inevitable, becoming more challenging to treat following each relapse. This makes it even more important that we maximise our best response upfront to extend the first remission,” said Professor Thierry Facon, Service des Maladies du Sang, Hôspital Claude Huriez, Lille, France, and principal investigator of the MAIA study. “This marks an important approval, especially for transplant ineligible patients, a more vulnerable population, for whom outcomes are generally poorer when compared to those who are transplant eligible,” he added.