FDA approves new indication for Janssen's Darzalex
Janssen Pharmaceuticals, of Johnson & Johnson, announced that it has received the Food and Drug Administration's blessing for a split-dosing regimen for Darzalex (daratumumab), an option to split the first infusion over two consecutive days for patients with multiple myeloma.
"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. We are committed to exploring options that may improve the overall treatment experience for patients," vice president, clinical development and global medical affairs, Janssen research and development, Craig Tendler said.
Darzalex is the first and only CD38-directed antibody to receive regulatory approval to treat multiple myeloma, according to the company.
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, or 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, making it the first monoclonal antibody approved for newly diagnosed patients with this disease.
In August 2012, Janssen Biotech and Genmab A/S entered into a global license and development agreement, which granted Janssen an exclusive license to develop, manufacture and commercialize Darzalex.
"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. We are committed to exploring options that may improve the overall treatment experience for patients," vice president, clinical development and global medical affairs, Janssen research and development, Craig Tendler said.
Darzalex is the first and only CD38-directed antibody to receive regulatory approval to treat multiple myeloma, according to the company.
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, or 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, making it the first monoclonal antibody approved for newly diagnosed patients with this disease.
In August 2012, Janssen Biotech and Genmab A/S entered into a global license and development agreement, which granted Janssen an exclusive license to develop, manufacture and commercialize Darzalex.