Breyanzi Approval History
Breyanzi Approval History
In the rapidly evolving field of cancer immunotherapy, CAR-T (Chimeric Antigen Receptor T-Cell) therapy has emerged as a groundbreaking treatment modality. Among the various CAR-T therapies, Breyanzi (lisocabtagene maraleucel) stands out as a pioneer in targeting B-cell malignancies. This article aims to provide a comprehensive overview of Breyanzi’s approval history, market access in various countries, and its clinical significance in treating cancer patients.
I. Breyanzi: A Brief Overview
Breyanzi is a CD19-directed CAR-T cell therapy developed by Bristol Myers Squibb (BMS). It represents a significant advancement in the field of cellular therapy, offering a potential curative option for patients with relapsed or refractory B-cell malignancies. The therapy involves the collection of a patient’s own T cells, genetic engineering to express a chimeric antigen receptor (CAR) that recognizes CD19, and subsequent reinfusion into the patient to target and eliminate CD19-positive B cells.
II. United States Approval and Market Access
Approval Date: February 5, 2021
Approved Indication: For the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy.
Breyanzi’s approval in the United States marked a significant milestone in the field of cancer immunotherapy. The therapy has since been made available to eligible patients across the country, providing a new hope for those suffering from relapsed or refractory B-cell malignancies.
Breyanzi (lisocabtagene maraleucel) was approved by the FDA on March 14, 2024 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 therapies, including a Bruton’s tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor. The approval was based on promising results from the TRANSCEND CLL 004 trial, demonstrating durable responses for some patients.
On May 15, 2024, the FDA approved Breyanzi for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior lines of systemic therapy.
On May 30, 2024, BMS announced that the FDA has approved Breyanzi for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least two prior lines of systemic therapy.
III. European Union Approval and Market Access
Approval Date: April 19, 2022
Approved Indication: For the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), and follicular lymphoma grade 3B (FL3B) after two or more lines of systemic therapy.
The approval of Breyanzi in the European Union represents a significant expansion of its global market access. Patients in Europe now have access to this innovative therapy, offering a potential curative option for their cancer treatment.
IV. United Kingdom Approval and Market Access
Approval Status: Currently under review by the Medicines and Healthcare Products Regulatory Agency (MHRA)
While Breyanzi has not yet been approved in the United Kingdom, it is under active review by the MHRA. Once approved, it is expected to provide patients in the UK with access to this transformative therapy.
V. Japan Approval and Market Access
Approval Date: March 28, 2021
Approved Indication: For the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL) and follicular lymphoma (FL).
Breyanzi’s approval in Japan represents a significant milestone in Asia, providing patients with access to this advanced immunotherapy. The therapy is now available for eligible patients in Japan, offering hope for those suffering from B-cell malignancies.
VI. China Approval Status
Approval Status: Currently under development and review by the National Medical Products Administration (NMPA)
While Breyanzi is not yet approved in China, it is under active development and review by the NMPA. With the increasing focus on cancer immunotherapy in China, it is expected that Breyanzi will soon be made available to patients in need.
VII. Conclusion
Breyanzi’s approval history and global market access demonstrate the significant progress made in the field of cancer immunotherapy. This innovative CAR-T therapy offers a potential curative option for patients with relapsed or refractory B-cell malignancies, providing new hope for cancer treatment. As the therapy continues to expand its global reach, it is expected to transform the lives of more patients worldwide.