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FDA Demands "Boxed Warning" to CAR T-Cell Therapy Labels
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The FDA has asked Gilead Sciences, Inc. (GILD - Free Report) , Johnson & Johnson (JNJ - Free Report) and Novartis (NVS - Free Report) to add “boxed warning” to the labels of their chimeric antigen receptor (CAR) T-cell immunotherapies, per Reuters.
The regulatory body sent letters to these companies stating that it had identified adverse events and clinical trial reports describing T-cell malignancies.
We remind readers that in November 2023, the FDA announced that it was investigating the identified risk of T-cell malignancy in patients who received treatment with CAR T-cell immunotherapies. These malignancies were reported in patients treated with almost all products in this class.
The FDA investigation followed reports received by the agency of T-cell malignancies in patients who received treatment with BCMA- or CD19-directed autologous CAR T-cell immunotherapies, which resulted in not just hospitalization of patients but, in certain cases, death as well. These reports came from ongoing clinical trials and/or postmarketing adverse event data sources.
CAR-T cell therapy is a type of cellular immunotherapy that involves using a patient’s immune cells to attack and get rid of harmful disease cells in the body. CAR T uses the patient’s cells to identify and destroy cancer cells, thereby making it different from other small molecule or biological therapies.
During the treatment, T cells are drawn from a patient's blood. These cells are then reprogrammed in the manufacturing facility to create genetically coded cells that are injected back into the patient. These then recognize and fight cancer cells.
The agency has determined that the risk of T-cell malignancies is applicable to all currently approved BCMA-directed and CD19-directed genetically modified autologous CAR T-cell immunotherapies.
Most of these therapies are approved for various forms of blood cancers. The FDA has approved six CAR T cell immunotherapies so far. These include Bristol Myers’ (BMY - Free Report) Abecma (idecabtagene vicleucel) and Breyanzi (lisocabtagene maraleucel), Gilead Sciences’ Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel), Novartis’ Kymriah and Johnson & Johnson’s Janssen and Legend Biotech’s (LEGN - Free Report) Carvykti (ciltacabtagene autoleucel).
Consequently, Novartis stated that it would update the prescribing information for its CAR-T cell therapy Kymriah to include instances of T-cell malignancies occurring after treatment with Kymriah. However, Novartis has not identified a causal relationship between Kymriah and secondary T-cell malignancies and remains confident about the therapy's profile.
Novartis’ Kymriah was the first to get approval in 2017 for the treatment of patients up to 25 years of age with B cell precursor acute lymphoblastic leukemia that is refractory or in second or later relapse.
Biotech giant Bristol Myers, too, confirmed the FDA's letters. BMY further added that it is evaluating the next steps on the labels for CAR T cell therapies, Abecma and Breyanzi, and it, too, has not observed any CAR-positive T-cell malignancy cases.
Bristol Myers is developing Abecma with partner 2seventy bio, Inc. Abecma is a CAR T-cell therapy indicated for adult patients with triple-class exposed relapsed or refractory multiple myeloma after four or more prior lines of therapy. Both these companies are also looking to get Abecma approved for earlier lines of therapy as well.
Legend Biotech earns collaboration revenues on product sales of Carvykti from Janssen. This CAR-T cell therapy was approved for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy.
Gilead acquired Kite Pharma to diversify into the field of cell therapy. Kite’s Yescarta is approved for the treatment of refractory aggressive non-Hodgkin lymphoma, including diffuse large B-cell lymphoma, transformed follicular lymphoma and primary mediastinal B-cell lymphoma. The company has one more therapy in its quiver, Tecartus, which is approved for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.
Image: Bigstock
FDA Demands "Boxed Warning" to CAR T-Cell Therapy Labels
The FDA has asked Gilead Sciences, Inc. (GILD - Free Report) , Johnson & Johnson (JNJ - Free Report) and Novartis (NVS - Free Report) to add “boxed warning” to the labels of their chimeric antigen receptor (CAR) T-cell immunotherapies, per Reuters.
The regulatory body sent letters to these companies stating that it had identified adverse events and clinical trial reports describing T-cell malignancies.
We remind readers that in November 2023, the FDA announced that it was investigating the identified risk of T-cell malignancy in patients who received treatment with CAR T-cell immunotherapies. These malignancies were reported in patients treated with almost all products in this class.
The FDA investigation followed reports received by the agency of T-cell malignancies in patients who received treatment with BCMA- or CD19-directed autologous CAR T-cell immunotherapies, which resulted in not just hospitalization of patients but, in certain cases, death as well. These reports came from ongoing clinical trials and/or postmarketing adverse event data sources.
CAR-T cell therapy is a type of cellular immunotherapy that involves using a patient’s immune cells to attack and get rid of harmful disease cells in the body. CAR T uses the patient’s cells to identify and destroy cancer cells, thereby making it different from other small molecule or biological therapies.
During the treatment, T cells are drawn from a patient's blood. These cells are then reprogrammed in the manufacturing facility to create genetically coded cells that are injected back into the patient. These then recognize and fight cancer cells.
The agency has determined that the risk of T-cell malignancies is applicable to all currently approved BCMA-directed and CD19-directed genetically modified autologous CAR T-cell immunotherapies.
Most of these therapies are approved for various forms of blood cancers. The FDA has approved six CAR T cell immunotherapies so far. These include Bristol Myers’ (BMY - Free Report) Abecma (idecabtagene vicleucel) and Breyanzi (lisocabtagene maraleucel), Gilead Sciences’ Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel), Novartis’ Kymriah and Johnson & Johnson’s Janssen and Legend Biotech’s (LEGN - Free Report) Carvykti (ciltacabtagene autoleucel).
Consequently, Novartis stated that it would update the prescribing information for its CAR-T cell therapy Kymriah to include instances of T-cell malignancies occurring after treatment with Kymriah. However, Novartis has not identified a causal relationship between Kymriah and secondary T-cell malignancies and remains confident about the therapy's profile.
Novartis’ Kymriah was the first to get approval in 2017 for the treatment of patients up to 25 years of age with B cell precursor acute lymphoblastic leukemia that is refractory or in second or later relapse.
Biotech giant Bristol Myers, too, confirmed the FDA's letters. BMY further added that it is evaluating the next steps on the labels for CAR T cell therapies, Abecma and Breyanzi, and it, too, has not observed any CAR-positive T-cell malignancy cases.
Bristol Myers is developing Abecma with partner 2seventy bio, Inc. Abecma is a CAR T-cell therapy indicated for adult patients with triple-class exposed relapsed or refractory multiple myeloma after four or more prior lines of therapy. Both these companies are also looking to get Abecma approved for earlier lines of therapy as well.
Legend Biotech earns collaboration revenues on product sales of Carvykti from Janssen. This CAR-T cell therapy was approved for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy.
Gilead acquired Kite Pharma to diversify into the field of cell therapy. Kite’s Yescarta is approved for the treatment of refractory aggressive non-Hodgkin lymphoma, including diffuse large B-cell lymphoma, transformed follicular lymphoma and primary mediastinal B-cell lymphoma. The company has one more therapy in its quiver, Tecartus, which is approved for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.
Each of these stocks currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.