FDA Approves Daratumumab Split-Dosing Regimen for Multiple Myeloma

New Administration Option for Patients

The FDA has approved a split-dosing regimen for daratumumab (DARZALEX, Janssen Biotech Inc.), giving healthcare professionals and patients with multiple myeloma the option of splitting the first infusion over two consecutive days. The approval is based on data from the global, multi-arm phase 1b EQUULEUS (MMY1001) clinical study, which demonstrated that daratumumab’s pharmacokinetic (PK) concentrations were comparable at the end of weekly dosing, regardless of whether the first dose was administered as a split or a single infusion.

Daratumumab is the first and only CD38-directed antibody to receive regulatory approval for the treatment of multiple myeloma. The drug received additional approvals in November 2016, June 2017, and most recently in May 2018 in combination with bortezomib, melphalan, and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.

Daratumumab is contraindicated in patients with a history of severe hypersensitivity (e.g., anaphylactic reactions) to daratumumab or any of the components of the formulation. It can cause severe and/or serious infusion reactions, including anaphylactic reactions. Severe reactions include bronchospasm, hypoxia, dyspnea, hypertension, laryngeal edema and pulmonary edema.

The most frequently reported adverse reactions were 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.

Source: Janssen, February 12, 2019