FDA OKs Bristol-Myers Squibb's Breyanzi To Treat Large-B-Cell Lymphoma

(RTTNews) - The U.S. Food and Drug Administration approved a new treatment for adult patients with certain types of large B-cell lymphoma (LBCL) who have not responded to, or who have relapsed after, at least two other types of systemic treatment.

Bristol-Myers Squibb's Breyanzi (lisocabtagene maraleucel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, is the third gene therapy to be approved by the FDA for certain types of cancer affecting the blood, bone marrow, and lymph nodes in adult patients.

However, Breyanzi is not indicated for the treatment of patients with primary central nervous system lymphoma.

According to the FDA, each dose of Breyanzi is a customized treatment created using a patient's own T-cells, a type of white blood cell, to help fight the lymphoma. The patient's T-cells are collected and genetically modified to include a new gene that facilitates targeting and killing of the lymphoma cells. Once the cells are modified, they are infused back into the patient.

The FDA approval of Breyanzi is based on data from the TRANSCEND NHL 001 (017001) multicenter clinical trial in which 268 patients with refractory or relapsed (R/R) LBCL received Breyanzi. This was the largest pivotal trial in third-line plus R/R LBCL that included patients with a broad range of histologies and high-risk disease.

In the trial, Breyanzi demonstrated a 73% overall response rate and 54% complete response (CR) rate. However, serious adverse reactions occurred in 46% of patients.

As part of the approval, the FDA is also requiring the dispensing of Breyanzi to be handled by healthcare facilities that are specially certified, since treatment with Breyanzi could cause severe side effects such as cytokine release syndrome (CRS).

Because of the risk of CRS and neurologic toxicities, Breyanzi is being approved with a Risk Evaluation and Mitigation Strategy (REMS) which includes Elements To Assure Safe Use (ETASU).

To further evaluate the long-term safety, the FDA is also requiring the manufacturer to conduct a post-marketing observational study involving patients treated with Breyanzi.

The FDA granted Breyanzi Orphan Drug, Regenerative Medicine Advanced Therapy (RMAT) and Breakthrough Therapy designations. RMAT designation helps facilitate the expeditious development of regenerative medicine therapies intended for serious conditions. Breyanzi is the first regenerative medicine therapy with RMAT designation to be licensed by the FDA.

Separately, Bristol Myers Squibb said it plans to manufacture Breyanzi for each individual patient at its state-of-the-art cellular immunotherapy manufacturing facility in Bothell, Washington.

Breyanzi offers a 24-day target turnaround time, and inpatient or outpatient administration options. BMS will offer patients disposable wearable technology during the initial post-infusion monitoring period, to help them track their temperature in real time through a smartphone when they are away from the treatment center.

Approximately 77,000 new cases of non-Hodgkin lymphoma are diagnosed in the U.S. each year and DLBCL represents approximately one in three newly diagnosed cases, According to the FDA.