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FDA approves Darzalex plus two standard-of-care regimens for multiple myeloma
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The FDA approved daratumumab for use in combination with two standard-of-care regimens for the treatment of patients with multiple myeloma who have received at least one prior therapy, according to the drug’s manufacturer.
The indications include daratumumab (Darzalex, Janssen Biotech) combined with lenalidomide (Revlimid, Celgene) — an immunomodulatory agent — and dexamethasone, or bortezomib (Velcade, Takeda Oncology) — a proteasome inhibitor — and dexamethasone.
The open-label POLLUX study showed the addition of daratumumab to lenalidomide and dexamethasone conferred a 63% reduction in the risk for disease progression or death (HR = 0.37; 95% CI, 0.27-0.52), as well as superior complete (25% vs. 12%) and partial response rates (32% vs. 24%).
The most frequent adverse reactions included infusion reactions (48 % vs. 0 %), diarrhea (43% vs. 25%), nausea (24% vs. 14%), fatigue (35% vs. 28%), pyrexia (20% vs. 11%), upper respiratory tract infection (65% vs. 51%), muscle spasms (26% vs. 19%), cough (30% vs. 15%) and dyspnea (21% vs. 12%).
The open-label CASTOR trial showed the addition of daratumumab to bortezomib and dexamethasone reduced the risk for disease progression or death by 61% (HR = 0.39; 95% CI, 0.28-0.53) and conferred superior ORR (79% vs. 60%).
The most frequent adverse reactions included infusion reactions (45% vs. 0%), diarrhea (32% vs. 22%), peripheral edema (22% vs. 13%), upper respiratory tract infection (44% vs. 30%), peripheral sensory neuropathy (47% vs. 38%), cough (27% vs. 14%) and dyspnea (21% vs. 11%).
The recommended dose of daratumumab is 16 mg/kg.
“We are proud of the rapid development and approval of daratumumab for use earlier in the treatment pathway, but our work does not stop here,” Peter F. Lebowitz, MD, PhD, global oncology head at Janssen Research & Development, said in a release. “We are only starting to uncover the full potential of this compound, and we remain committed to the continued study of daratumumab to more fully understand its utility for patients with multiple myeloma and other cancer types.”