{"id":59045,"date":"2024-03-15T04:02:24","date_gmt":"2024-03-15T03:02:24","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/u-s-fda-approves-bristol-myers-squibbs-breyanzi-as-the-first-and-only-car-t-cell-therapy-for-adults-with-relapsed-or-refractory-chronic-lymphocytic-leukemia-cll-or-small-lymphocytic\/"},"modified":"2024-03-15T04:02:24","modified_gmt":"2024-03-15T03:02:24","slug":"u-s-fda-approves-bristol-myers-squibbs-breyanzi-as-the-first-and-only-car-t-cell-therapy-for-adults-with-relapsed-or-refractory-chronic-lymphocytic-leukemia-cll-or-small-lymphocytic","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/u-s-fda-approves-bristol-myers-squibbs-breyanzi-as-the-first-and-only-car-t-cell-therapy-for-adults-with-relapsed-or-refractory-chronic-lymphocytic-leukemia-cll-or-small-lymphocytic\/","title":{"rendered":"U.S. FDA Approves Bristol Myers Squibb\u2019s Breyanzi\u00ae as the First and Only CAR T Cell Therapy for Adults with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)"},"content":{"rendered":"
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\nBreyanzi offers a personalized treatment option delivered as a one-time infusion that provides deep and durable responses for patients with relapsed or refractory CLL or SLL who have historically had no standard of care<\/i><\/b><\/p>\n

\nIn TRANSCEND CLL 004, the first pivotal multicenter trial to evaluate a CAR T cell therapy in <\/i>patients with relapsed or refractory CLL or SLL,<\/i> 20% of patients treated with <\/i>Breyanzi achieved a complete response (CR) with median duration of CR not reached, along with an established safety profile<\/i><\/b><\/p>\n

\nBreyanzi is now FDA approved for relapsed or refractory large B-cell lymphoma and CLL or SLL, bringing this differentiated CD19-directed CAR T cell therapy to more patients<\/i><\/b><\/p>\n

PRINCETON, N.J.–(BUSINESS WIRE)–$BMY<\/a> #Breyanzi<\/a>—Bristol Myers Squibb<\/a> (NYSE: BMY) today announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Breyanzi<\/i>\u00ae <\/sup>(lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least two prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). In R\/R CLL or SLL, Breyanzi <\/i>is delivered through a treatment process which culminates in a one-time infusion* with a single dose containing 90 to 110 x 106<\/sup> CAR-positive viable T cells. Please see the Important Safety Information section below, including Boxed WARNINGS<\/b> for Breyanzi <\/i>regarding Cytokine Release Syndrome (CRS), Neurologic Toxicities, and Secondary Hematological Malignancies.<\/p>\n

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\n\u201cCAR T cell therapies represent a transformative treatment option for patients with certain types of blood cancers,\u201d said Bryan Campbell, senior vice president, Head of Commercial, Cell Therapy, Bristol Myers Squibb. \u201cFor years, attempts to bring other CAR T cell therapies to patients with relapsed or refractory CLL or SLL met challenges and found little success. With the approval of Breyanzi <\/i>as the first CAR T for relapsed or refractory CLL or SLL, we are now able to offer these patients a personalized option, while further expanding access across the broadest array of B-cell malignancies, to address this critical unmet need.\u201d<\/p>\n

\nCLL and SLL are among the most common types of B-cell lymphoma. Treatments for people living with CLL or SLL primarily consist of targeted therapies including BTK- and BCL-2 inhibitors. However, patients often experience relapse or become refractory following early-line treatment with these therapies and there is no established standard of care for patients with double-class exposed CLL or SLL. After relapsing or becoming refractory to these therapies, patients have few options and poor outcomes, including lack of durable complete responses.<\/p>\n

\nThe Phase 1\/2 open-label, single-arm TRANSCEND CLL 004 study was the first pivotal multicenter trial to evaluate a CAR T cell therapy in patients with relapsed or refractory CLL or SLL. The CR rate associated with Breyanzi <\/i>treatment was 20% (95% CI: 11.1-31.8). Among patients who achieved a CR, median duration of response was not reached (95% CI: 15 months-NR) at the time of data cutoff. Among all responders (ORR = 45%; 95% CI: 32.3-57.5), median duration of response was 35.3 months (95% CI: 12.4-NR). High rates of minimal residual disease (MRD) negative status were observed across patients treated with Breyanzi <\/i>who achieved a CR,<\/i> with an MRD-negativity rate of 100% in the blood (95% CI: 75.3-100) and 92.3% in the bone marrow (95% CI: 64-99.8).<\/p>\n

\n\u201cCLL and SLL are currently considered incurable diseases with few treatment options in the relapsed setting that can confer complete responses, something that has historically been associated with improved long-term outcomes,\u201d said Tanya Siddiqi, M.D., lead investigator and Associate Professor, Division of Lymphoma, City of Hope National Medical Center. \u201cThe FDA approval of liso-cel in relapsed or refractory CLL and SLL after treatment with prior BTKi and BCL2i is a remarkable breakthrough, shifting the treatment paradigm from continuous therapy with sequential regimens to overcome drug resistance, to a one-time personalized T-cell based approach that has the potential to offer patients complete and lasting remission.\u201d<\/p>\n

\nAmong 89 patients in the study treated with Breyanzi, <\/i>occurrences of cytokine release syndrome (CRS) and neurologic events (NEs) were mostly low grade. Any grade CRS occurred in 83% of patients, with Grade 3 CRS occurring in 9% of patients. No Grade 4\/5 CRS events were reported. Any grade NEs were reported in 46% of patients, with Grade 3 NEs reported in 20% of patients and one case of Grade 4 NE reported. No Grade 5 NEs were reported.<\/p>\n

\n\u201cFor people struggling with relapsed or refractory CLL or SLL, current treatment choices are limited,\u201d said Dr. Brian Koffman, physician, CLL patient and cofounder, executive vice president and chief medical officer of CLL Society. \u201cThe approval of Breyanzi <\/i>as the first CAR T cell therapy available for relapsed or refractory CLL or SLL brings new hope to these patients with the potential for durable responses after a single CAR T infusion. We are grateful to the patients and their families who enter the trials and to all the researchers involved in making possible this important new treatment option in CLL and SLL.\u201d<\/p>\n

\nBristol Myers Squibb offers various programs and resources to address the needs of patients and caregivers, and provides support that allows for access to therapies, including Breyanzi. <\/i>Bristol Myers Squibb also supports the patient and physician treatment experience by providing Cell Therapy 360<\/a>, a digital service platform, which optimizes access to relevant information, manufacturing updates, and patient and caregiver support.<\/p>\n

\nAbout TRANSCEND CLL 004<\/span><\/b><\/p>\n

\nTRANSCEND CLL 004 (NCT03331198) is a Phase 1\/2 open-label, single-arm, multicenter study evaluating Breyanzi<\/i> in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma. The Phase 1 dose escalation portion of the study assessed the safety and recommended dose for the subsequent Phase 2 expansion cohort. The Phase 2 portion of the study is evaluating Breyanzi<\/i> at the recommended dose from the Phase 1 monotherapy arm. The primary endpoint of the Phase 2 portion of the study is complete response rate, including complete remission with incomplete bone marrow recovery, based on independent review committee according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 guidelines.<\/p>\n

\nAbout CLL and SLL<\/span><\/b><\/p>\n

\nChronic 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 grows, there is less room for healthy white blood cells, red blood cells and platelets. Small lymphocytic lymphoma (SLL) also affects the lymphocytes, with cancer cells found mostly in the lymph nodes. While there are several treatments available for CLL and SLL, there is a need for additional effective therapies as there is no standard of care for relapsed or refractory CLL or SLL after prior therapy with targeted agents, such as Bruton tyrosine kinase (BTK) and B-cell lymphoma 2 (BCL-2) inhibitors. Patients with relapsed or refractory disease have limited treatment options and generally experience shorter periods of response with each subsequent treatment.<\/p>\n

\nAbout Breyanzi<\/i><\/span><\/b><\/p>\n

\nBreyanzi is <\/i>a CD19-directed CAR T cell therapy with a 4-1BB costimulatory domain, which enhances the expansion and persistence of the CAR T cells. Breyanzi <\/i>is made from a patient\u2019s own T cells, which are collected and genetically reengineered to become CAR T cells that are then delivered via infusion as a one-time treatment.<\/p>\n

\nBreyanzi<\/i> is approved in the U.S., Japan and Europe for the second-line treatment of relapsed or refractory LBCL, and in Japan, Europe, Switzerland, and Canada for relapsed and refractory LBCL after two or more lines of systemic therapy. Bristol Myers Squibb\u2019s clinical development program for Breyanzi<\/i> includes clinical studies in other types of lymphoma. For more information, visit clinicaltrials.gov<\/a>.<\/p>\n

\n*<\/i> <\/i>Treatment process includes leukapheresis, manufacturing, administration, and adverse event monitoring.<\/i><\/p>\n

\nIndication<\/span><\/b><\/p>\n

\nBREYANZI is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:<\/p>\n