Darzalex is approved by FDA for use in combination with Celgene’s Revlimid and dexamethasone for multiple myeloma patients not eligible for stem cell transplants.
Darzalex (daratumumab) from Johnson & Johnson is a monoclonal antibody approved for the treatment of various patients with multiple myeloma. It can be used alone to treat patients that have received at least three prior medicines, including a proteasome inhibitor and an immunomodulatory agent, or who did not respond to a proteasome inhibitor and an immunomodulatory agent. It is also approved in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, to treat patients who have received at least one prior medicine. In combination with Velcade, Melphalan and Prednisone (VMP), it can be used for the treatment of newly diagnosed patients who are not eligible for a stem cell transplant.
Now Darzalex can also be used in combination with Celgene’s Revlimid and dexamethasone for newly diagnosed multiple myeloma patients not eligible for stem cell transplants. This latest approval from the FDA was based on results of a phase III clinical study that showed a 44% reduction in the risk of myeloma progression or death compared with treatment with Revlimid and dexamethasone alone. The approval was granted under the FDA’s Real-Time Oncology Review pilot program.
Altogether, Darzalex has six approvals for the treatment of multiple myeloma patients, with two now for first-line use in newly diagnosed patients. In May 2019, it was the first monoclonal antibody approved by the FDA for use in newly diagnosed patients (in combination with Takeda’s Velcade and prednisone).