Johnson & Johnson (J&J) is widening its lead over competitors in the multiple myeloma (MM) treatment field by spearheading an early intervention strategy. While existing treatments have focused on patients after symptom onset, J&J is pioneering the first attempt to proactively apply treatment to patients in the high-risk smoldering multiple myeloma (HR-SMM) stage, before symptoms appear.
HR-SMM has been viewed as an untreated area and a blue ocean with no approved therapies to date. J&J is strengthening its dominance in the full-cycle treatment portfolio by adding the convenience of a subcutaneous (SC) formulation, which requires less administration time and has fewer side effects than traditional intravenous injections.
Potential First Treatment for HR-SMM: FDA Advisory Committee Issues Positive Recommendation
On Friday, industry sources reported that the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA) recently voted 6-2 in favor of recommending the SC formulation of Darzalex Faspro (daratumumab) for the treatment of high-risk smoldering multiple myeloma (HR-SMM). This signals a high likelihood of final FDA approval.
Currently, there are no FDA-approved treatments for HR-SMM patients. The standard approach has been observation and waiting, with no intervention until the disease progresses to an active stage and organ damage is confirmed. However, J&J’s recent advisory committee vote opens the possibility of a new paradigm: intervening before disease progression.
The reviewed data were based on J&J’s Phase 3 AQUILA clinical trial results. Darzalex Faspro significantly reduced the risk of progression or death compared to the observation group. These findings, presented at last year’s American Society of Hematology (ASH) meeting and simultaneously published in the New England Journal of Medicine (NEJM), garnered significant attention from the medical community.
Completing the Multiple Myeloma Full-Cycle Portfolio: Differentiation from Competitors
If Darzalex Faspro receives FDA approval for the HR-SMM indication, J&J will effectively complete its strategy for treating multiple myeloma across all stages. Until now, multiple myeloma treatment has focused on newly diagnosed multiple myeloma (NDMM) or relapsed and refractory multiple myeloma (RRMM) stages, but it will now extend to the pre-symptomatic stage. HR-SMM accounts for about 15% of all MM cases, with over half expected to progress to active disease within 2 to 3 years.
The strategic differences from competitors are clear. Bristol-Myers Squibb (BMS) targets relapsed patients with its BCMA Target CAR-T therapy, Abecma, while Sanofi uses its CD38 mechanism treatment, Sarclisa, in intravenous injection form. Takeda’s Ninlaro offers the convenience of an oral formulation but is limited to combination therapy.
If Darzalex Faspro receives approval for the HR-SMM indication, J&J is poised to become the first and only pharmaceutical company to enter this competitor-free blue ocean. J&J submitted its application for this indication to the FDA last November, and an approval decision is expected soon.
