Eu grants conditional approval to Darzalex (daratumumab) in multiple myeloma- Genmab

Genmab announced that the European Commission (EC) has granted a conditional marketing authorization for CD38 antibody Darzalex (daratumumab). The conditional approval 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 and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.

The EC approval follows a positive opinion issued for Darzalex by the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) in April 2016. The marketing authorization was based on data from the Phase II study (SIRIUS MMY2002, published in The Lancet in January 2016), the Phase I/II GEN501 monotherapy study (published in The New England Journal of Medicine in August 2015) 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 overall survival for single-agent daratumumab (16 mg/kg) in these heavily pre-treated patients was 20 months (95 percent Confidence Interval, 15 months to not yet estimable). The overall response rate for the combined analysis was 31 percent, and 83 percent of patients achieved stable disease or better.

Comment: Current competitors are Kyprolis (carfilzomib) from Amgen and Pomalyst (pomalidomide) from Celgene. Coming to market are elotuzumab (now called by trade name, Empliciti) from BMS + AbbVie and ixazomib from Takeda.