On the heels of game-changing trial results presented at last year's American Society of Hematology meeting, Johnson & Johnson is introducing what it calls a "foundational frontline therapy" in multiple myeloma and at the same time expanding its already impressive presence in the field.
Late Tuesday, the company said the FDA has approved its quadruplet combination of Darzalex Faspro and VRd, the abbreviated combination name for Takeda’s Velcade, Bristol Myers Squibb’s Revlimid and the steroid dexamethasone, for induction and consolidation in patients with newly diagnosed multiple myeloma who are eligible for an autologous stem cell transplant.
The approval is supported by data from J&J's phase 3 PERSEUS trial, which showed that the quadruplet combination slashed the risk of disease progression or death by 60% compared with VRd, J&J said in a press release. The trial tested the regimens in first-line multiple myeloma patients who were eligible for stem cell transplants.
At the ASH conference last year, PERSEUS investigator Pieter Sonneveld, M.D., Ph.D., from the Erasmus MC Cancer Institute in the Netherlands, called the magnitude of progression-free survival (PFS) benefit recorded by the researchers "unprecedented."
In its release, J&J noted that patients will be able to receive the quadruplet therapy quickly after their diagnosis, offering the opportunity for "significantly" better outcomes.
Darzalex Faspro is the subcutaneous version of J&J's stalwart multiple myeloma drug Darzalex, which was first approved in 2015. All told, the franchise generated $9.74 billion worldwide last year. Darzalex Faspro uses Halozyme's drug delivery technology called Enhanz.
Before the latest nod, Darzalex has also been approved as part of a quadruplet with Velcade, thalidomide and dexamethasone in first-line, transplant-eligible myeloma patients; and with Velcade, melphalan and prednisone in transplant-ineligible patients.
Besides the Darzalex franchise, J&J's other multiple myeloma drugs are Legend Biotech-partnered CAR-T Carvykti plus the bispecifics Tecvayli and Talvey.
Put succinctly during an investor event last year, J&J CEO Joaquin Duato said the company's goal is "that the vast majority of the newly diagnosed multiple myeloma patients would be treated with a Johnson & Johnson regimen."