Europe extends Darzalex approval as multiple myeloma treatment
Approval covers quadruple regimen, regardless of transplant eligibility
The European Commission has extended its approval of Johnson & Johnson’s Darzalex (daratumumab) for injection under the skin as part of a quadruple regimen for first-line treatment of adults with newly diagnosed multiple myeloma.
The quadruple regimen includes the subcutaneous (under-the-skin) formulation of Darzalex, marketed in the U.S. as Darzalex Faspro, in combination with bortezomib, lenalidomide, and dexamethasone — a standard triple therapeutic regimen known as VRd. Bortezomib is marketed as Velcade, while lenalidomide is branded as Revlimid. Both are available as generics.
“This landmark approval enables us to offer all patient populations access regardless of age, fitness or risk to a [Darzalex]-based triplet or quadruplet regimen in the frontline setting — a critical step towards our ultimate goal of delivering a functional cure,” Jordan Schecter, MD, vice president and multiple myeloma area leader at Johnson & Johnson Innovative Medicine, said in a company press release.
Darzalex can now be used in the European Union in nine indications for multiple myeloma, five of which are for front-line treatment, in adult patients regardless of whether they are eligible for autologous stem-cell transplant (ASCT), a common treatment for multiple myeloma that uses a patient’s own stem cells.
Multiple myeloma is a type of blood cancer that forms from abnormal plasma cells, a type of immune cell that develops from B-cells. This type of cancer can be difficult to treat because it is often resistant to available treatment options. It also frequently relapses, meaning it can return after treatment.
‘Cornerstone’ of multiple myeloma treatment
Darzalex is an antibody that attaches to CD38, a protein found on the surface of plasma cells, including the abnormal ones in multiple myeloma. When Darzalex attaches to CD38, it activates the immune system to destroy the abnormal plasma cells, which is expected to ease symptoms.
Darzalex “has become a cornerstone of multiple myeloma treatment over the past decade and is now the only anti-CD38 antibody approved to treat all patient types in the frontline setting, regardless of transplant eligibility,” said Edmond Chan, MD, Johnson & Johnson Innovative Medicine’s hematology area leader in Europe, the Middle East, and Africa.
The latest approval was based on positive data from CEPHEUS (NCT03652064), an ongoing Phase 3 clinical trial involving 395 adults with newly diagnosed multiple myeloma who were either ineligible for ASCT or for whom ASCT was deferred. They were randomly assigned to receive either Darzalex-VRd or VRd alone.
After a median 59 months, or nearly five years, the proportion of patients with no detectable multiple myeloma cells was significantly higher in the Darzalex-VRd group (60.9% vs. 39.4%). These patients were also 43% less likely to die or experience disease progression than those assigned to VRd alone.
“Starting with more effective regimens in the frontline setting offers patients the best chance of sustained long-term outcomes by preventing disease resistance and relapse,” said Katja Weisel, MD, a professor at University Medical Centre Hamburg-Eppendorf in Germany.
No unexpected side effects occurred during the CEPHEUS trial. The most common severe to life-threatening side effects reported with Darzalex-VRd were low counts of blood cells and clotting platelets, nerve damage, diarrhea, and COVID-19.
Darzalex-VRd “delivers an effective and convenient new standard of care for patients with newly diagnosed multiple myeloma, regardless of transplant eligibility, with responses that are deep and durable, and translate into significantly reduced risk of disease progression or death,” Weisel said.
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