RARITAN, N.J. - Johnson & Johnson (NYSE:JNJ) has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for a new indication of its DARZALEX FASPRO® treatment in combination with other drugs for newly diagnosed multiple myeloma patients not eligible for autologous stem cell transplant (ASCT).
The sBLA is based on results from the Phase 3 CEPHEUS study, which revealed that 60.9% of patients achieved minimal residual disease (MRD)-negativity using the DARZALEX FASPRO® combination, and it reduced the risk of disease progression or death by 43% compared to an alternative regimen. The CEPHEUS study is the first to use MRD-negativity as its primary endpoint in a trial for multiple myeloma, recently supported by an FDA advisory committee vote.
DARZALEX FASPRO® is a subcutaneous formulation of daratumumab, a CD38-directed antibody, combined with hyaluronidase. It is currently approved for multiple myeloma across various treatment settings and is being evaluated further in the ongoing PERSEUS study, which is not designed to isolate the effect of DARZALEX FASPRO® during the maintenance phase of treatment.
Multiple myeloma is a blood cancer affecting plasma cells in the bone marrow, with an estimated 35,000 new cases diagnosed in the U.S. in 2024. DARZALEX FASPRO® has been a part of the treatment landscape since its FDA approval in May 2020 and is the only subcutaneous CD38-directed antibody approved for multiple myeloma.
The safety profile of the DARZALEX FASPRO® combination was consistent with known profiles of the individual therapies. The CEPHEUS study enrolled 396 patients across 13 countries, while the PERSEUS study is being conducted in 14 countries in Europe and Australia.
The information in this article is based on a press release statement from Johnson & Johnson.
In other recent news, Johnson & Johnson has reported significant advancements in treatments for multiple myeloma. Clinical trials have shown that the company's CARVYKTI and DARZALEX FASPRO treatments, when used in combination with other drugs, significantly improve patient outcomes. The Phase 3 CARTITUDE-4 study indicated that CARVYKTI improves overall survival rates, while the Phase 3 AURIGA and CEPHEUS studies demonstrated the effectiveness of DARZALEX FASPRO in improving patient outcomes and reducing the risk of disease progression.
In addition, the Phase 1b RedirecTT-1 study revealed promising efficacy for a novel bispecific antibody combination therapy in treating relapsed or refractory multiple myeloma. Johnson & Johnson has also expanded the rollout of its TECNIS Odyssey intraocular lens across the U.S., a development aimed at enhancing vision for cataract patients. These developments are part of the company's ongoing commitment to improving patient health outcomes through innovative treatment options.
In legal news, Johnson & Johnson's subsidiary, Red River Talc LLC, filed for a prepackaged Chapter 11 bankruptcy as part of a strategy to settle ongoing ovarian cancer claims related to cosmetic talc litigation in the U.S. Goldman Sachs has reiterated its Buy rating on shares of CG Oncology following new data presented by Johnson & Johnson. Lastly, Johnson & Johnson announced the retirement of Executive Vice President and Chief Human Resources Officer, Dr. Peter M. Fasolo, with Kristen Mulholland named as his successor. These are some of the recent developments at Johnson & Johnson.
InvestingPro Insights
Johnson & Johnson's recent submission of a supplemental Biologics License Application for DARZALEX FASPRO® aligns with the company's strong position in the pharmaceutical industry. According to InvestingPro data, J&J boasts a substantial market capitalization of $389.18 billion, underlining its significant presence in the healthcare sector.
The company's focus on innovative treatments like DARZALEX FASPRO® is reflected in its solid financial performance. J&J reported a revenue of $86.58 billion in the last twelve months as of Q2 2024, with a revenue growth of 5.13% over the same period. This growth trajectory supports the company's ability to invest in research and development for new drug applications.
InvestingPro Tips highlight J&J's financial stability and shareholder-friendly policies. The company has raised its dividend for 53 consecutive years, demonstrating a commitment to returning value to shareholders. This is particularly relevant given the potential for increased revenue from expanded indications for treatments like DARZALEX FASPRO®.
Moreover, J&J is trading at a low P/E ratio relative to its near-term earnings growth, suggesting potential upside for investors as the company continues to expand its product portfolio. The stock's low price volatility also indicates stability, which may be attractive to investors looking for steady growth in the pharmaceutical sector.
For readers interested in a deeper analysis, InvestingPro offers 11 additional tips for Johnson & Johnson, providing a comprehensive view of the company's financial health and market position.
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