PBS Listing Extended for Daratumumab

The Pharmaceutical Benefits Scheme (PBS) listing for daratumumab has been extended to include first-line treatment of multiple myeloma. Patients must be ineligible for a primary stem cell transplant and treatment must form part of triple combination therapy that is limited to daratumumab, lenalidomide, and dexamethasone.

Daratumuab is a targeted immunotherapy that inhibits the growth of cells expressing the CD38 protein. This protein is overexpressed on the surface of cells in many haematological malignancies, including multiple myeloma. Studies have shown that daratumumab induces multiple myeloma cell death via several mechanisms, including complement-dependent cytotoxicity, antibody-dependent cell-mediated cytotoxicity, antibody-dependent cellular phagocytosis, and apoptosis.

A Phase 3 trial in patients with newly diagnosed multiple myeloma compared the safety and efficacy of daratumumab plus dexamethasone and lenalidomide to dexamethasone and lenalidomide alone. Median progression-free survival was significantly longer in the daratumumab group (44.5 months vs 17.5 months), and the risk of disease progression or death was 44% lower compared to the control group.

The most common serious adverse events reported were neutropenia, anaemia, lymphopenia, and pneumonia. Daratumumab may also cause infusion-related reactions, particularly with the first dose. Reactions can include nasal congestion, chills, and throat irritation. However, serious reactions, including anaphylaxis have been reported. Infusion-related reactions are more common with intravenous administration than subcutaneous.