UCI Health acquires four Tenet hospitals in Orange and Los Angeles counties, expanding services. Tenet's recent USD 975 Million deal follows multiple hospital sell-offs, hinting at over USD 1 Billion in forthcoming funds.

Belgium: The FDA has given its approval to Janssen's and Legend Biotech's ciltacabtagene autoleucel (cilta-cel), marketed as Carvykti, for an extended use in adult patients with relapsed and lenalidomide-refractory multiple myeloma (MM) who have undergone at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent.

This decision follows an evaluation of data from the CARTITUDE-4 clinical trial (NCT04181827), a phase 3 study comparing cilta-cel to standard of care (SOC) therapy in patients who had received 1 to 3 prior lines of treatment. The latest findings from CARTITUDE-4 were presented at the American Society of Clinical Oncology (ASCO) 2023 Annual Meeting by Binod Dhakal, MD, associate professor at the Medical College of Wisconsin.

In CARTITUDE-4, 206 patients were randomly assigned to receive cilta-cel while 211 received SOC therapy, which consisted of pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (DPd). As of June 2023, 176 patients had received cilta-cel with 143 continuing to be monitored post-treatment, and 77 patients were still undergoing SOC therapy.

The results showed that patients in the cilta-cel group had a 12-month progression-free survival (PFS) rate of 76%, compared to 49% in the SOC group. Cilta-cel demonstrated improved PFS in patients with 1 or 2-3 prior lines of treatment, with potentially stronger benefits seen in those with only 1 prior therapy. Dhakal highlighted at ASCO that cilta-cel's safety profile in CARTITUDE-4 was similar to other studies but with lower rates of neurotoxicity than seen in CARTITUDE-1.

Johnson & Johnson, in their press release regarding the FDA approval, noted that in CARTITUDE-4, cilta-cel reduced the risk of disease progression or death by 59% compared to SOC therapies. The press release also outlined safety considerations, mentioning a boxed warning for various potential adverse events such as cytokine release syndrome, neurotoxicity, Parkinsonism, Guillain-Barre syndrome, hemophagocytic lymphohistiocytosis/macrophage activation syndrome, cytopenias, and secondary malignancies.

Legend Biotech submitted the supplemental biologics license application (BLA) for this expanded indication in June 2023. A United States Securities and Exchange Commission (SEC) filing on January 23, 2024, revealed that the supplemental BLA underwent review by the FDA's Oncologic Drugs Advisory Committee (AdComm), which convened on March 15, 2024. The AdComm members unanimously voted in favor of cilta-cel's benefit-risk profile for patients with relapsed and lenalidomide-refractory MM after at least 1 prior line of therapy, including specific prior treatments.

The FDA's main concern regarding cilta-cel centered on overall survival (OS), noting an increased rate of early deaths in cilta-cel-treated patients compared to SOC, which is a known aspect of autologous CAR-T therapy. While acknowledging similarities to early deaths seen with treatments like stem cell transplants, the FDA stated that it cannot definitively conclude better overall survival with cilta-cel due to immature data and unclear causes of early deaths.

In response, the sponsor provided a restricted mean survival time analysis on PFS, showing a difference favoring cilta-cel, and attributed early deaths to disease progression before cilta-cel, COVID-19, and cilta-cel as subsequent therapy.

Cilta-cel initially received FDA approval in February 2022 for the treatment of adult patients with relapsed/refractory MM following 4 or more prior lines of therapy, with a specific treatment regimen. The mechanism of cilta-cel involves targeting B-cell maturation antigen (BCMA).

Binod Dhakazl, MD, Associate Professor, Medical College of Wisconsin, Division of Hematology and Oncology, said, “CARVYKTI demonstrated remarkable efficacy as a personalized, one-time infusion in the earlier treatment of relapsed/refractory multiple myeloma as shown through the CARTITUDE-4 study results. With this approval, I’m excited for patients who may have the opportunity for a treatment-free period for their multiple myeloma as early as first relapse, with the hope of eliminating the burden of having to be on continuous treatment while living with this challenging disease.”

Jordan Schecter, MD, Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine, said, “This milestone underscores our commitment to improve outcomes for patients and transform the treatment of multiple myeloma with CARVYKTI. We are proud to bring an important, highly effective immunotherapy that has demonstrated a favorable benefit/risk profile to physicians and patients for the earlier treatment of relapsed/refractory multiple myeloma, and we look forward to building on this latest milestone as we continue to focus on our ultimate goal of delivering a cure for multiple myeloma.”

According to TechSci Research, the FDA's approval of Janssen's and Legend Biotech's ciltacabtagene autoleucel (cilta-cel), marketed as Carvykti, for an expanded indication in multiple myeloma (MM) has significant implications for the healthcare market.

This approval is likely to boost the growth of the CAR-T cell therapy market segment. CAR-T cell therapy has been gaining traction in recent years due to its promising outcomes in treating certain types of cancer, including Multiple Myeloma. With this expanded approval, there is now a broader patient population eligible for treatment with cilta-cel. As a result, the demand for CAR-T cell therapies is expected to rise, leading to increased market size and revenue potential for companies operating in this space.

Moreover, the approval of cilta-cel for patients with relapsed and lenalidomide-refractory MM who have received at least one prior line of therapy fills an unmet medical need. Patients in this population often have limited treatment options, and CAR-T therapy offers a novel approach that has shown efficacy in clinical trials. This approval opens up a new avenue of treatment for these patients, potentially improving their outcomes and quality of life.

Additionally, the FDA's decision is likely to encourage further research and development in the field of CAR-T cell therapies. Pharmaceutical and biotechnology companies may be more inclined to invest in developing similar therapies for other types of cancer or for different stages of MM. This could lead to a pipeline of innovative CAR-T cell products entering clinical trials and eventually reaching the market, further expanding the healthcare market's offerings.

Furthermore, the approval of cilta-cel highlights the importance of personalized medicine and targeted therapies in oncology. CAR-T cell therapies are designed to target specific antigens on cancer cells, offering a more precise and tailored approach to treatment. As the healthcare industry continues to move towards personalized medicine, the demand for therapies like cilta-cel is expected to grow, driving market expansion.