The new indication is the seventh overall for the therapy, according to Janssen.
FDA has approved daratumumab, sold by Janssen as Darzalex, in combination with bortezomib, thalidomide, and dexamethasone to treat patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant, according to a statement from the company.
Thursday’s approval is based on results from the phase 3 CASSIOPEIA study, which showed that adding daratumumab to the triple therapy combination both before and after transplant brought better responses, including a 53% reduction in the risk of disease progression or death compared with the triple therapy alone.
The approval, the seventh indication for the therapy, came after FDA had granted Janssen Priority Review status for the supplemental Biologics License Application.
Previously, daratumumab was approved in combination with bortezomib, melphalan and prednisone for patients newly diagnosed with multiple myeloma who are ineligible for autologous stem cell transplant. And in June, the drug was approved with combination for lenalidomide and dexamethasone to treat newly diagnosed multiple myeloma patients who cannot receive an autologous stem cell transplant.
Daratumumab is also approved in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for patients with multiple myeloma who have had at least 1 prior therapy. It is approved with pomalidomide and dexamethasone for patients with 2 previous treatments.
“The pivotal phase 3 CASSIOPEIA study is one of the largest transplant studies ever conducted in multiple myeloma, and the largest study ever with daratumumab,” said Philippe Moreau, MD, principal investigator and head of the Hematology Department, University Hospital of Nantes, France. “It’s important that patients get a deep response from their frontline therapy,” he said, and this phase 3 study showed that adding daratumumab to the triple combination both before and after transplant increased response compared with the triple combination alone.
The Multiple Myeloma Research Foundation’s Paul Giusti, president and CEO, praised the milestone. “We are thrilled that newly diagnosed patients with multiple myeloma and their doctors have a new option with this combination,” he said.