The monoclonal antibody Darxalex (daratumumab) was recently approved by the U.S. Food and Drug Administration (FDA), in combination with either Revlimid (lenalidomide) and dexamethasone, or Velcade (bortezomib) and dexamethasone, as a treatment for multiple myeloma patients who have received at least one prior therapy.
“With Darzalex, we are able to offer a treatment to our multiple myeloma patients who have tried at least one other therapy. Along the way, our oncology team of pharmacists, nurses, and care coordinators works hard to provide a consistent high level of care to support them at all times as they grapple with multiple myeloma,” Paul Urick, company president, said in a news release.
Darzalex is a monoclonal antibody that promotes the activity of immune cells against myeloma cells. It binds to the protein CD38, found at the surface of many myeloma cells, helping the immune cells to ‘find’ the malignant cells and to kill them.
Darzalex became the first CD38 antibody approved for use in November 2015, when FDA gave it accelerated approval as a monotherapy for myeloma patients who have received at least three prior lines of therapy. Prior therapies included a proteasome inhibitor, like Velcade, and an immunomodulatory agent, like Revlimid.
In November 2016, the FDA extended Darzalex’s indications to be used in combination therapy in refractory myeloma patients.
The latest approval was based on data from two Phase 3 clinical trials: the POLLUX (MMY3003) trial, and the CASTOR (MMY3004) study.
POLLUX (NCT02076009) was designed to assess the efficacy of Darzalex in combination with Revlimid and dexamethasone in patients with relapsed of refractory myeloma. The trial showed improved overall response (91% vs. 71%) and progression-free survival outcomes (not reached vs. 18.4 months) in the Darzalex group, compared to those receiving Revlimid plus dexamethasone alone.
CASTOR (NCT02136134) evaluated the efficacy of an Darzalex, Velcade, and dexamethasone triple combination, also in patients with relapsed or refractory myeloma. The treatment group showed higher progression free-survival (not reached vs 7.2 months) and overall response rate (79% vs. 60%), compared to the group receiving Velcade and dexamethasone alone.