Janssen Pharmaceuticals has requested the U.S. Food and Drug Administration (FDA) add a new indication for Darzalex (daratumumab) in combination with other therapies to treat patients with multiple myeloma ... Read more
A new study reports that the specific type of multiple myeloma (MM) may affect how long the drug Darzalex (daratumumab) remains in circulation, affecting its effectiveness for the treatment ... Read more
Genmab announced that its partner Janssen Biotech will launch three novel studies to investigate the effect of Darzalex (daratumumab) in patients with multiple myeloma. The Danish company says its agreement ... Read more
Janssen Biotech will discuss at a Chicago cancer conference the effectiveness of new multiple myeloma treatment combinations that include its therapy Darzalex (daratumumab). The United States and European Union approved ... Read more
The monoclonal antibody Darxalex (daratumumab) was recently approved by the U.S. Food and Drug Administration (FDA), in combination with either Revlimid (lenalidomide) and dexamethasone, or Velcade (bortezomib) and dexamethasone, as ... Read more
The U.S. Food and Drug Administration (FDA) has approved Darzalex (daratumumab), in combination with Revlimid (lenalidomide) and dexamethasone, or Velcade (bortezomib) and dexamethasone, for multiple myeloma patients who have ... Read more
The anti-CD38 agent Darzalex (daratumumab) will be investigated in a Phase 3 clinical trial in combination with Kyprolis (carfilzomib) and Decadron (dexamethasone) in relapsed/refractory multiple myeloma patients. The study will ... Read more
A three-drug therapy combination consisting of Darzalex (daratumumab) with Revlimid (lenalidomide) and Decadron (dexamethasone) shows real potential in increasing survival in patients with relapsed or refractory multiple myeloma, according to an ... Read more
Janssen Biotech has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) to expand Darzalex (daratumumab) to include patients with multiple myeloma. The ... Read more
Adding Darzalex (daratumumab) to the treatment of multiple myeloma with Velcade (bortezomib) and dexamethasone significantly improved progression-free survival in a clinical trial of patients who had relapsed or did not respond to standard treatment.
Darzalex, an antibody targeting the CD38 molecule on cancer cells, was approved by the U.S. Food and Drug Administration (FDA) for the treatment of relapsing multiple myeloma in November 2015. The study provided additional support for the effectiveness of the drug.
The Phase 3 clinical trial (NCT02136134) randomized 498 patients to receive either 1.3 mg of Velcade per square meter of body surface area and 20 mg of dexamethasone, given to 247 patients; or the two drugs together with an add-on of 16 mg per kg body weight Darzalex to 251 patients.
Patients in the Darzalex group received the drug once weekly during the first three 21-day study cycles, then once every three weeks during cycles 4-9, and then once every four weeks until disease progression, unacceptable side effects, or the patient wished to leave the study.
Researchers from the University of Turin in Italy report that at 12 months, patients in the Darzalex combination group had a progression-free survival rate of 60.7 percent, while the control group on Velcade and dexamethasone reached only 26.9 percent.
Following the patients for a median of 7.4 months, the control group had a median progression-free survival of 7.2 months, while it was not possible to calculate the median for the Darzalex patients, since so few had disease progression.
Also, the rate of overall response was higher among patients treated with Darzalex, (82.9 versus 63.2 percent), and more patients had at least a partial (59.2 versus 29.1 percent), or complete (19.2 versus 9 percent) response.
Patients in both groups had equally frequent side effects, but a greater proportion of severe side effects were seen in the Darzalex group, including loss of blood platelets, red blood cells, or white blood cells called neutrophils,
Nearly half of patients in this group also got reactions linked to the infusion of Darzalex, 98.2 percent of which occurred during the first infusion. These reactions were mostly mild or moderate, however.
“In the [Darzalex] group, deep, rapid, and durable responses were reported, with the rates of very good partial response or better and complete response or better approximately double those in the control group,” the researchers wrote.
Pin It on Pinterest