The European Medicines Agency (EMA) has recommended that Darzalex (daratumumab) be approved in Europe, in combination with Revlimid (lenalidomide) and dexamethasone, as a first-line treatment for multiple myeloma patients who are ineligible for autologous stem cell transplant (ASCT).
Janssen announced the positive opinion by the EMA’s Committee for Medicinal Products for Human Use (CHMP) on a type II variation application, which refers to any major change in a therapy’s marketing authorization that may have a strong impact on its quality, safety, or efficacy, but does not involve changes in its active ingredient, dosage, or mode of administration.
In the coming months, the European Commission is expected to decide whether or not to expand the existing marketing authorization for Darzalex in the European Union (EU), based on CHMP’s recommendation.
If approved, this expansion will follow the recent approval of the Darzalex combination therapy for the same patient group by the U.S. Food and Drug Administration in June 2019. Janssen is also seeking the combination’s approval for the same indication in Japan.
“We are encouraged that the CHMP are recommending a broadening of the current Darzalex marketing authorization in the European Union to include Darzalex in combination with lenalidomide and dexamethasone as a possible treatment for patients newly diagnosed with multiple myeloma,” Jan van de Winkel, PhD, Genmab’s CEO, said in a news release.
Winkel emphasized that, with this approval, this group of myeloma patients would have another treatment option in the EU, besides the already EMA-approved combination of Darzalex with Velcade (bortezomib), melphalan, and prednisone standard therapy.
Darzalex, created by Genmab, and developed and commercialized by Janssen Pharmaceuticals, is an antibody that recognizes and blocks the activity of CD38, a protein found in high numbers on the surface of myeloma cells, regardless of disease severity. By binding to CD38, Darzalex not only kills cancer cells directly, but also triggers an immune response that helps to destroy the cancer.
CHMP’s positive opinion was based on data from the multicenter, randomized, open-label MAIA Phase 3 trial (NCT02252172), which assessed whether the addition of Darzalex to standard Revlimid and dexamethasone (Rd) — DRd combo — was better than standard treatment alone.
MAIA included 737 people newly diagnosed with multiple myeloma who were not eligible for ASCT. Participants were recruited across more than 210 centers in North America, Europe, Australia, and Israel, and randomly assigned to receive either DRd combo therapy or Rd treatment until the occurrence of disease progression or unacceptable adverse effects.
At a median follow-up of 28 months, the DRd combo therapy had reduced the risk of disease progression or death by 44% compared with the standard Rd treatment.
Also, Darzalex nearly doubled the number of patients achieving a complete response — 47.6% versus 24.9% in the control group — and more than tripled those who achieved minimal residual disease negativity — 24.2% versus 7.3%.
Minimal residual disease is the small number of myeloma cells that remain in the body after treatment is complete, which may cause disease relapse.
Consistent with previous studies, the addition of Darzalex to standard treatment increased the rates of some adverse effects, compared with Rd therapy alone. However, fewer people in the combination group discontinued treatment due to adverse reactions — 7.1% versus 15.9%.
In Europe, Darzalex has three approvals for the treatment of people with multiple myeloma, including one for those who have just been diagnosed.
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