Darzalex’s revenue trends
Johnson & Johnson’s (JNJ) Darzalex generated revenues of $432.0 million in the first quarter compared to $255.0 million in the first quarter of 2017, reflecting ~69.4% YoY (year-over-year) growth.
Darzalex generated first-quarter revenues of $264.0 million and $168.0 million from sales in the US and international markets, respectively. In the US market, Darzalex witnessed ~31.3% YoY growth in the first quarter.
Label expansion approval for Darzalex
In May, the FDA approved Darzalex, Takeda Pharmaceutical’s (TKPYY) Velcade, melphalan, and prednisone (or VMP) combination therapy for the treatment of individuals with newly diagnosed multiple myeloma who aren’t eligible for ASCT (autologous stem cell transplant).
Darzalex became the first approved monoclonal antibody for the treatment of newly diagnosed individuals with multiple myeloma. With the label expansion approval by the FDA, Darzalex became approved for the fifth indication in multiple myeloma. The label expansion of Darzalex is expected to boost the revenue growth of the drug. The FDA approval of Darzalex and VMP combination therapy was based on the data from the Phase 3 ALCYONE trial.
In the ALCYONE trial, Darzalex and VMP combination therapy decreased the risk of disease progression or death by 50.0% compared to VMP therapy. In the clinical trial, Darzalex and VMP combination therapy demonstrated overall response rate (or ORR) of 91.0% compared to 74.0% for patients on VMP therapy.
Also, 18.0%, 43.0%, and ~71.0% of patients on Darzalex and VMP combination therapy demonstrated a stringent complete response, complete response or better, and very good partial response, respectively, compared to ~7.0%, ~24.0%, and ~50.0% of patients on Darzalex and VMP therapy.
Among Darzalex’s peers in the multiple myeloma market, Amgen’s (AMGN) Kyprolis, Celgene’s (CELG) Pomalyst, and Bristol-Myers Squibb’s (BMY) Empliciti reported revenues of $222.0 million, $453.0 million, and $55.0 million, respectively, in the first quarter.