CHMP recommends Darzalex (daratumumab) as a treatment for relapsed and refractory multiple myeloma. Janssen Cilag

Janssen-Cilag International NV announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a Positive Opinion recommending a conditional marketing authorisation for first-in-class CD38 immunotherapy Darzalex (daratumumab) in the European Union. The recommended indication is for monotherapy of adult patients with relapsed and refractory multiple myeloma (MM), whose prior therapy included a proteasome inhibitor (PI) and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.

This application was reviewed under an accelerated assessment by the CHMP, a process reserved for medicinal products expected to be of major public health interest, particularly from the point of view of therapeutic innovation.

The Opinion of the CHMP was based on a review of data from the Phase II MMY2002 (SIRIUS) study, published in The Lancet, the Phase 1/II GEN501 study, published in The New England Journal of Medicine, and data from three additional supportive studies. These studies included heavily pre-treated patients with relapsed and refractory multiple myeloma who had exhausted other approved treatment options and whose disease was progressive at enrolment. Findings from a combined efficacy analysis of the GEN501 and MMY2002 (SIRIUS) trials demonstrated that after a mean follow-up of 14.8 months, the estimated median OS for single-agent daratumumab (16 mg/kg) in these heavily pre-treated patients was 20 months (95 percent CI, 15-not estimable). The overall response rate (ORR) for the combined analysis was 31 percent, and 83 percent of patients achieved stable disease or better.