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The Food and Drug Administration has approved a split-dosing regimen for daratumumab (Darzalex) in patients with multiple myeloma, allowing the first infusion to be split over 2 days.
FDA approval is based on results from the global, multi-arm, phase 1b EQUULEUS (MMY1001) trial, which evaluated daratumumab in combination with a variety of treatment regimens. Splitting the first infusion over 2 consecutive days reduced the duration of the infusion and resulted in a similar rate of infusion site reactions; concentrations were similar at the end of weekly dosing in patients who received the first infusion at once or over a 2-day period.
The adverse events reported in EQUULEUS (MMY1001) were largely similar to those seen in previous trials; the most common adverse events include infusion reactions, neutropenia, thrombocytopenia, fatigue, nausea, diarrhea, constipation, vomiting, muscle spasms, arthralgia, back pain, pyrexia, chills, dizziness, insomnia, cough, dyspnea, peripheral edema, peripheral sensory neuropathy, and upper respiratory tract infection.
The approval providers “added flexibility for how patients may receive initial treatment,” Craig Tendler, MD, vice president of clinical development and global medical affairs at Janssen Research & Development, said in a statement.
The Food and Drug Administration has approved a split-dosing regimen for daratumumab (Darzalex) in patients with multiple myeloma, allowing the first infusion to be split over 2 days.
FDA approval is based on results from the global, multi-arm, phase 1b EQUULEUS (MMY1001) trial, which evaluated daratumumab in combination with a variety of treatment regimens. Splitting the first infusion over 2 consecutive days reduced the duration of the infusion and resulted in a similar rate of infusion site reactions; concentrations were similar at the end of weekly dosing in patients who received the first infusion at once or over a 2-day period.
The adverse events reported in EQUULEUS (MMY1001) were largely similar to those seen in previous trials; the most common adverse events include infusion reactions, neutropenia, thrombocytopenia, fatigue, nausea, diarrhea, constipation, vomiting, muscle spasms, arthralgia, back pain, pyrexia, chills, dizziness, insomnia, cough, dyspnea, peripheral edema, peripheral sensory neuropathy, and upper respiratory tract infection.
The approval providers “added flexibility for how patients may receive initial treatment,” Craig Tendler, MD, vice president of clinical development and global medical affairs at Janssen Research & Development, said in a statement.
The Food and Drug Administration has approved a split-dosing regimen for daratumumab (Darzalex) in patients with multiple myeloma, allowing the first infusion to be split over 2 days.
FDA approval is based on results from the global, multi-arm, phase 1b EQUULEUS (MMY1001) trial, which evaluated daratumumab in combination with a variety of treatment regimens. Splitting the first infusion over 2 consecutive days reduced the duration of the infusion and resulted in a similar rate of infusion site reactions; concentrations were similar at the end of weekly dosing in patients who received the first infusion at once or over a 2-day period.
The adverse events reported in EQUULEUS (MMY1001) were largely similar to those seen in previous trials; the most common adverse events include infusion reactions, neutropenia, thrombocytopenia, fatigue, nausea, diarrhea, constipation, vomiting, muscle spasms, arthralgia, back pain, pyrexia, chills, dizziness, insomnia, cough, dyspnea, peripheral edema, peripheral sensory neuropathy, and upper respiratory tract infection.
The approval providers “added flexibility for how patients may receive initial treatment,” Craig Tendler, MD, vice president of clinical development and global medical affairs at Janssen Research & Development, said in a statement.