Chimeric antigen receptor (CAR) T-cell therapy is a type of immunotherapy that uses the patient's own T. Therapies with the patient's genetically modified CAR T cells are approved by the United States Food and Drug Administration (FDA) to treat certain types of lymphomas and leukemias, as well as multiple myeloma. CAR T cell therapy is usually used after other types of treatment have been tried. Breyanzi offers a personalized treatment option that is administered as a single infusion that provides deep and lasting responses to patients with relapsed or treatment-resistant CLL or SLL who have not historically received any standard treatment.
In TRANSCEND CLL 004, the first pivotal multicenter trial to evaluate CAR T cell treatment in patients with relapsed or refractory CLL or SLL, 20% of patients treated with Breyanzi achieved a complete response (CR) with the median of duration of CR, together with an established safety profile Breyanzi is now FDA-approved for relapses or refractory large B-cell lymphoma and CLL or SLL, bringing this differentiated CAR T-cell therapy aimed at CD19 to more patients. CLL and SLL are among the most common types of B-cell lymphoma. Treatments for people living with CLL or SLL consist primarily of targeted therapies that include BTK and BCL-2 inhibitors. However, patients often relapse or become resistant to treatment after initial treatment with these treatments, and there is no established standard treatment for patients with dual exposure to CLL or SLL. After relapsing or becoming refractory to these treatments, patients have few options and the outcomes are unfavorable, such as the lack of complete and lasting responses.
Bristol Myers Squibb offers several programs and resources to address the needs of patients and caregivers, and provides support that allows access to therapies, including Breyanzi therapy. Bristol Myers Squibb also supports the treatment experience of patients and doctors by providing Cell Therapy 360, a digital service platform that optimizes access to relevant information, manufacturing updates, and support for patients and caregivers. Chronic lymphocytic leukemia (CLL) is one of the most common types of leukemia in adults. In CLL, too many blood stem cells in the bone marrow become abnormal lymphocytes, and these abnormal cells have difficulty fighting infections.
As the number of abnormal cells increases, there is less room for healthy white blood cells, red blood cells, and platelets. Small lymphocytic lymphoma (SLL) also affects lymphocytes, and cancer cells are found primarily in the lymph nodes. While several treatments are available for CLL and SLL, additional effective therapies are needed, as there is no standard treatment for recurrent or treatment-resistant CLL or SLL after previous treatment with targeted drugs, such as Bruton tyrosine kinase (BTK) inhibitors and B-cell lymphoma 2 (BCL). Patients with relapsed or treatment-resistant disease have limited treatment options and generally experience shorter response periods with each subsequent treatment. Breyanzi is a CAR-T cell therapy aimed at the CD19 group with a 4-1BB costimulatory domain, which improves the expansion and persistence of T lymphocytes.
Breyanzi is made from the patient's own T cells, which are collected and genetically redesigned to become CAR T cells that are then administered by infusion as a single treatment. Breyanzi is approved in the U.S. UU. Bristol Myers Squibb's clinical development program for Breyanzi includes clinical studies in other types of lymphoma.
Fatal or fatal neurological effects occurred after treatment with BREYANZI, including immune effector cell-associated neurotoxicity syndrome (ICANS).). Serious events, such as cerebral edema and seizures, occurred with BREYANZI. There were also fatal and serious cases of leukoencephalopathy, some attributable to fludarabine. Monitoring of CRS and neurological toxicities with the BREYANZI infusion, allergic reactions may occur.
Serious hypersensitivity reactions, including anaphylaxis, may be due to dimethyl sulfoxide (DMSO). Monitor patients for signs and symptoms of infection before and after administration of BREYANZI and treat them appropriately. Administer prophylactic antimicrobials in accordance with standard institutional guidelines. Avoid administering BREYANZI to patients with clinically significant active systemic infections.
Patients treated with BREYANZI can develop secondary malignancies. T-cell malignancies have occurred after treatment of hematological malignancies with genetically modified autologous T-cell immunotherapies targeting BCMA and CD19, including BREYANZI. Mature T-cell malignancies, including CAR-positive tumors, may appear as soon as weeks after the infusion and may result in fatal outcomes. In the event of a secondary malignancy, contact Bristol-Myers Squibb at 1-888-805-4555 for information and instructions on collecting patient samples for analysis.
Effects on the ability to drive and use machines Because of the possibility of neurological events, such as changes in mental state or seizures, patients receiving BREYANZI are at risk of impaired or decreased consciousness or coordination problems within 8 weeks of administering BREYANZI. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, for at least 8 weeks. Immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS) See full prescribing information, including warnings in the boxes and the medication guide. Bristol Myers Squibb is inspired by a unique vision that transforms patients' lives through science.
The goal of the company's cancer research is to offer drugs that offer each patient a better and healthier life and that enable healing. Building on the legacy of a wide range of cancers that have changed the survival expectations of many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine and, through innovative digital platforms, are turning data into information that sharpens their approach. Deep knowledge of human causal biology, cutting-edge capabilities and differentiated research platforms uniquely position the company to address cancer from all angles. Cancer can relentlessly encompass many aspects of a patient's life, and Bristol Myers Squibb is committed to taking steps to address all aspects of care, from diagnosis to survival.
As a leader in cancer care, Bristol Myers Squibb works so that everyone with cancer can have a better future. The remarkable results of CAR-T cell therapy were considered a clinical success; however, from a commercial perspective, CAR-T therapy has achieved minimal success. CAR-T therapy is currently the most effective therapy for its approved indications, but the cell-killing capacity of cells is not limited to cancer cells alone. While CD19 and BCMA are the only antigens for which there are FDA-approved CAR T cell therapies, CAR T cell therapies have been developed that target other antigens commonly found in blood cancers, including therapies that attack several antigens at once.
For patients interested in learning more about the availability of CAR T cell therapies, consult this resource for a directory of medical institutions that offer at least one FDA-approved CAR T cell therapy. The addition of a suicide gene to CAR-T cells leads to the selective destruction of adoptively transferred cells, as well as to the selective ablation of genetically modified cells, which avoids the indirect effect of CAR-T therapy and the toxicity of the therapy. This review will demonstrate the challenges of CAR-T cell therapy in the treatment of cancer and will propose possible strategies for optimizing therapy. with CAR cells.
