Janssen seeks EU approval for extended use of Darzalex

US healthcare giant Johnson & Johnson (NYSE: JNJ) subsidiary Janssen has submitted an application to the European Medicines Agency to broaden the existing marketing authorization for its immunotherapy Darzalex (daratumumab) to include treatment of adult patients with relapsed multiple myeloma who have received one or more lines of therapy.

This submission is based on data from two Phase III studies showing daratumumab in combination with standard of care regimens resulted in a reduction in the risk of disease progression or death. These study results underscore the potential of Darzalex as a foundational therapy for relapsed multiple myeloma patients, and both were featured at major medical meetings (ASCO and EHA).

Only three months ago, Darzalex received its first European Commission approval for monotherapy treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three prior lines of therapy.