Genmab announces that the Committee for Medicinal Products (CHMP) for Human Use of the European Medicines Agency (EMA) has issued a positive opinion recommending the grant of a conditional marketing authorization for DARZALEX (daratumumab) in the European Union.
The recommendation is for the use of DARZALEX as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor (PI) and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.
The positive opinion of the CHMP was predominantly based on data from the Phase II study (SIRIUS MMY2002, published in The Lancet in January 2016) of daratumumab in multiple myeloma patients who have received at least three prior lines of therapy including both a PI and an immunomodulatory agent, or who are double refractory to a PI and an immunomodulatory agent. Additional data from four other studies, including the Phase I/II GEN501 monotherapy study (published in The New England Journal of Medicine in August 2015) support the opinion. In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop, manufacture and commercialize daratumumab.
“We are very pleased to receive the positive opinion from the CHMP for the use of DARZALEX as monotherapy in patients with relapsed and refractory multiple myeloma. The CHMP opinion brings Genmab and its partner Janssen one step closer towards offering a fundamentally new treatment option to patients with multiple myeloma in Europe, and we look forward to the decision of the European Commission,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
A CHMP opinion is one of the final steps in the regulatory process of the European Medicines Agency. The CHMP reviewed DARZALEX under the EMA’s accelerated assessment program. A final decision by the European Commission is anticipated in 60 – 90 days.
In November 2015, DARZALEX was approved by the U.S. FDA under a Breakthrough Therapy Designation and Priority Review for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.