The
Food and Drug Administration (FDA) announced their approval of
daratumumab in combination with lenalidomide and dexamethasone for
patients with newly diagnosed multiple myeloma who are not eligible for
autologous stem cell transplant.
“Today’s
approval of DARZALEX (daratumumab) underscores the significant clinical
benefit of this CD38 monoclonal antibody and our efforts to advance
treatment paradigms to change the course of the disease,” said Craig
Tendler, M.D., Vice President, Clinical Development and Global Medical
Affairs, Oncology, Janssen Research & Development, LLC in a press
release. “Importantly, this milestone also highlights the efficiency of
the FDA’s Real-Time Oncology Review process, ensuring that proven
treatment regimens, such as DARZALEX plus lenalidomide and
dexamethasone, are made available to patients as soon as possible.”
The
decision for approval was made based on results of MAIA, an open-label,
randomized (1:1) phase III study comparing dartumumab (16 mg/kg) in
combination with lenalidomide and low-dose dexamethasone (DRd) to
lenalidomide and low-dose dexamethasone (Rd), in 737 patients.
The
trial showed an improvement in progression-free survival (PFS) with DRd
compared with Rd. The median PFS had not been reached in the DRd arm and
was 31.9 months in the Rd arm (HR 0.56; 95% CI: 0.43, 0.73;
p<0.0001). The median time to response was 1.05 months (range: 0.2 to
12.1 months) in the DRd group and 1.05 months (range: 0.3 to 15.3
months) in the Rd group. The median response duration had not been
reached in the DRd group and was 34.7 months (95% CI: 30.8, not
estimable) in the Rd group.
In
the DRd arm, the most frequent (≥20%) adverse reactions were infusion
reactions, diarrhea, constipation, nausea, peripheral edema, fatigue,
back pain, asthenia, pyrexia, upper respiratory tract infection,
bronchitis, pneumonia, decreased appetite, muscle spasms, peripheral
sensory neuropathy, dyspnea and cough.
Daratumumab
can cause severe and/or serious infusion reactions, including
anaphylactic-related ones. Patients should be pre‑medicated with
antihistamines, antipyretics and corticosteroids and frequently
monitored during the entire infusion. The recommended daratumumab dose
is 16 mg/kg actual body weight.
Get to know more about Hematology & Oncology at World Hematology
Source: https://www.cancernetwork.com/multiple-myeloma/fda-approves-daratumumab-combination-multiple-myeloma
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