BRUSSELS – The European Commission has granted approval to CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) who have received at least one prior therapy. This marks cilta-cel as the first BCMA CAR-T therapy available in Europe for patients at an earlier stage of relapse, potentially altering the course of treatment for the incurable blood cancer.
Cilta-cel targets B-cell maturation antigen (BCMA), a protein prevalent on myeloma cells, and is a personalized cell therapy. The approval is based on findings from the Phase 3 CARTITUDE-4 study, which showed a significant reduction in the risk of disease progression or death compared to standard care. At a median follow-up of 15.9 months, patients treated with cilta-cel had a progression-free survival rate that was not yet estimable, in contrast to 11.8 months for those receiving standard care.
The study also reported an 85 percent overall response rate and a 73 percent complete response rate or better for cilta-cel patients. In addition, cilta-cel patients demonstrated a higher minimal residual disease negativity rate compared to the standard care group.
Despite the promising outcomes, the therapy is associated with serious adverse events, such as hematologic toxicities including neutropenia, thrombocytopenia, and anemia. Cytokine release syndrome, a common side effect of CAR-T treatments, was observed in 76 percent of cilta-cel recipients, with 1 percent experiencing severe cases.
The European Commission’s decision also included the upgrade of cilta-cel’s conditional marketing authorization to standard, indicating that the post-approval obligations have been fulfilled. This approval follows a similar decision by the U.S. Food and Drug Administration earlier this month.
Janssen-Cilag International NV, part of Johnson & Johnson, emphasizes the potential of cilta-cel to transform treatment outcomes for patients with multiple myeloma, aiming for sustained remissions. This approval provides a new therapeutic option for patients who typically face resistance to standard treatments and whose disease progresses with each additional line of therapy.
This article is based on a press release statement from Janssen-Cilag International NV.
InvestingPro Insights
The recent approval of CARVYKTI® (cilta-cel) by the European Commission is a significant milestone for Janssen-Cilag International NV and its parent company, Johnson & Johnson (JNJ). As investors and stakeholders consider the potential market impact of this new treatment option for multiple myeloma, it is important to look at the financial health and market performance of Johnson & Johnson.
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InvestingPro Data for Johnson & Johnson shows:
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