FDA Approves Split Daratumumab Dosing Regimen for Myeloma Treatment

The FDA approved a split-dosing regimen for daratumumab (Darzalex) for the treatment of patients with multiple myeloma, according to the Janssen Pharmaceutical Companies of Johnson & Johnson, the manufacturer of the agent.

The approval, which is based off data from the phase Ib EQUULEIS (MMY1001) trial, will now allow healthcare providers to split the dosing into 2 days.

“The first infusion of Darzalex is an important first step in a patient’s course of therapy, and this approval provides added flexibility for how patients may receive initial treatment,” Craig Tendler, M.D., vice president, clinical development and global medical affairs, Janssen Research & Development, LLC., said in a statement.

EQUULEUS (MMY1001) was a global, multi-arm trial that compared daratumumab to various treatment regimens. Splitting the drug’s dosing between 2 days effectively reduced the duration of the first infusion and resulted in similar rate and pattern of infusion reaction. daratumumab concentrations were comparable at the end of weekly dosing, regardless of whether the initial dose of 16 mg/kg was given as a single or split infusion in the first regimen.

The most frequently reported adverse events, which occurred in 20% or more of patients who received daratumumab included: 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 FDA originally approved daratumumab in November 2015 as a monotherapy for patients with myeloma who previously received 3 or more lines of therapy. It was later approved in 2016 in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone for the treatment of patients with myeloma who had at least 1 prior therapy. Later, in June 2017, daratumumab was approved in combination with pomalidomide and dexamethasone for the treatment of patients with myeloma who had at least 2 prior therapies. Finally, in May 2018, daratumumab was approved in combination with bortezomib, melphalan and prednisone for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.

“We are committed to exploring options that may improve the overall treatment experience for patients,” Tendler said.