FDA Approves Split Darzalex Dosing Regimen for Myeloma Treatment

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

The approval, which is based off data from the phase 1b EQUULEIS (MMY1001) trial, will now allow health care providers to split the dosing into two 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 of clinical development and global medical affairs at Janssen Research & Development, LLC., said in a statement.

EQUULEUS (MMY1001) was a global, multi-arm trial that compared Darzalex to various treatment regimens. Splitting the drug’s dosing between two days effectively reduced the duration of the first infusion and resulted in similar rate and pattern of infusion reaction. Darzalex 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 side effects, which occurred in 20 percent or more of patients who received Darzalex 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 Darzalex in November 2015 as a monotherapy for patients with myeloma who previously received three 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 one prior therapy. Later, in June 2017, Darzalex was approved in combination with pomalidomide and dexamethasone for the treatment of patients with myeloma who had at least two prior therapies. Finally, in May 2018, Darzalex 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.