Janssen Submits U.S. & EU Regulatory Applications Seeking Approval of DARZALEX® (daratumumab) Split Dosing Regimen

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) and a type II variation to the European Medicines Agency (EMA) seeking approval of a split dosing regimen for DARZALEX® (daratumumab). The applications seek to update the Prescribing Information and Summary of Product Characteristics to provide health care professionals with the option to split the first infusion of DARZALEX® over two consecutive days. The submissions are supported by data from the Phase 1b MMY1001 clinical trial, which demonstrated DARZALEX® pharmacokinetics (PK) concentrations were comparable regardless of whether the first dose was administered as a split infusion or single first infusion in patients with multiple myeloma. The safety profile of DARZALEX® was comparable when administered initially as a split or single dose.1

“We are committed to exploring options that may improve the administration profile of DARZALEX® and the overall treatment experience for patients and physicians,” said Craig Tendler, MD, Vice President, Clinical Development and Global Medical Affairs, Janssen Research & Development, LLC. “We look forward to reviewing the data in support of these applications with regulators and hope to make a DARZALEX® split-dose option available to patients and health care professionals to provide additional flexibility in administration of the initial infusion.”

The regulatory submission is based on data from the global, multi-arm Phase 1b MMY1001 study in multiple myeloma, which evaluated DARZALEX® in combination with various treatment regimens. Splitting the first dose of DARZALEX®effectively reduced the duration of the first infusion and resulted in a similar rate and pattern of infusion reactions. Data from MMY1001 demonstrated that DARZALEX® concentrations were comparable after administration of the first 16 mg/kg dose regardless of whether it was administered as a split infusion or single first infusion in all approved indications. No new safety events were observed with split dosing.

In the United States of America, DARZALEX® first received FDA approval in November 2015 as a monotherapy for patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent, or who are double refractory to a PI and an immunomodulatory agent. DARZALEX®received additional approvals in November 2016 in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy. In June 2017, DARZALEX® received approval in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a PI. Most recently, in May 2018, DARZALEX® received approval 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 (ASCT), making it the first monoclonal antibody approved for newly diagnosed patients with this disease.

In the European Union (EU), DARZALEX® first received European Commission approval in May 2016 as a monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent, and who have demonstrated disease progression on the last therapy.  DARZALEX®received an additional approval in April 2017 for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. Finally, in July 2018, DARZALEX® received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) recommending broadening the existing marketing authorization for use in combination with bortezomib, melphalan, and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).

In August 2012, Janssen Biotech, Inc. and Genmab A/S entered into a global license and development agreement, which granted Janssen an exclusive license to develop, manufacture, and commercialize DARZALEX. – Medical Buyer Bureau

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