J&J Highlights New Frontline Multiple Myeloma Treatment with Darzalex Faspro's FDA Approval
Johnson & Johnson is fortifying its position in the fight against multiple myeloma following a new FDA approval. Building on the success of groundbreaking trial results presented at the previous year's American Society of Hematology (ASH) meeting, the company is launching what it describes as a "foundational frontline therapy" for multiple myeloma. This move also extends its already significant footprint in the field.
Johnson & Johnson announced that the FDA has approved its quadruplet combination therapy, which includes Darzalex Faspro, Velcade (from Takeda), Revlimid (from Bristol Myers Squibb), and the steroid dexamethasone. This combination is intended for induction and consolidation in newly diagnosed multiple myeloma patients who qualify for an autologous stem cell transplant.
The FDA's approval is based on data from Johnson & Johnson's phase 3 PERSEUS trial. This trial demonstrated that the quadruplet combination reduced the risk of disease progression or death by 60% compared to the use of VRd alone. The trial involved first-line multiple myeloma patients eligible for stem cell transplants. At the ASH conference last year, Dr. Pieter Sonneveld from the Erasmus MC Cancer Institute in the Netherlands described the progression-free survival (PFS) benefit observed in the trial as "unprecedented."
Johnson & Johnson emphasized in their release that patients can receive the quadruplet therapy soon after diagnosis, which could lead to "significantly" improved outcomes. Darzalex Faspro, the subcutaneous version of Johnson & Johnson's well-established multiple myeloma drug Darzalex, played a critical role in the combination. Approved initially in 2015, the Darzalex franchise generated $9.74 billion globally last year. Darzalex Faspro employs Halozyme's drug delivery technology, Enhanz.
Prior to this latest approval, Darzalex had already been sanctioned for use in other quadruplet combinations: with Velcade, thalidomide, and dexamethasone for transplant-eligible first-line patients, and with Velcade, melphalan, and prednisone for transplant-ineligible patients.
In addition to the Darzalex franchise, Johnson & Johnson’s multiple myeloma portfolio includes the CAR-T therapy Carvykti, developed in partnership with Legend Biotech, and the bispecific antibodies Tecvayli and Talvey.
During an investor event last year, Johnson & Johnson's CEO, Joaquin Duato, stated the company's ambition clearly: "The vast majority of the newly diagnosed multiple myeloma patients would be treated with a Johnson & Johnson regimen."
With this new FDA approval, Johnson & Johnson continues to solidify its leadership in the treatment of multiple myeloma, aiming to provide better therapeutic options and improve patient outcomes significantly.
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