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May 16, 2024

US FDA Approves Expanded Use of Bristol Myers’ Cancer Cell Therapy for Follicular Lymphoma

The US Food and Drug Administration (FDA) has approved the expanded use of Bristol Myers Squibb’s cancer cell therapy, Breyanzi, to treat adults with follicular lymphoma. This decision allows Breyanzi to be administered to patients whose cancer has recurred or has not responded to previous treatments, marking the fourth approval for this innovative therapy.

Follicular lymphoma, a common type of non-Hodgkin lymphoma, typically affects individuals aged 50 and older. This slow-growing cancer, characterized by periods of remission and relapse, becomes increasingly challenging to treat after each relapse. According to US government data, the incidence rate of non-Hodgkin lymphoma stands at 18.6 per 100,000 people per year.

Breyanzi, first approved in 2021 for large B-cell lymphoma, is a chimeric antigen receptor (CAR) T-cell therapy. CAR T-cell therapies work by genetically modifying T-cells, a type of white blood cell, to target and destroy cancer cells. The recent FDA approval now extends Breyanzi’s use to patients with follicular lymphoma who have undergone two or more prior lines of therapy.

Bryan Campbell, head of commercial cell therapy at Bristol Myers, highlighted the significance of this approval. “This expanded approval provides an option with the potential for lasting remission in a one-time infusion and a safety profile that supports administration and monitoring in a growing number of certified treatment centers across the US,” he stated.

The approval is backed by promising data from a mid-stage clinical study. In this study, Breyanzi achieved complete remission in 94% of patients who had previously received at least two treatments. Additionally, 97% of the participants experienced either complete disappearance or significant reduction of cancer signs following Breyanzi therapy.

Bristol Myers expects this expanded approval to significantly increase the market potential for Breyanzi. The company is also scaling up its manufacturing capacity for CAR-T therapies, including Breyanzi and Abecma, in response to growing demand.

CAR-T cell therapies represent a cutting-edge approach in cancer treatment. By harnessing the body’s immune system to fight cancer, these therapies offer new hope for patients with difficult-to-treat cancers. Other notable cell therapies in this category include Novartis’ Kymriah and Gilead Sciences’ Yescarta, which have shown efficacy in treating various types of blood cancers.

Breyanzi’s approval for follicular lymphoma comes as a significant advancement, providing a new treatment avenue for patients who have exhausted other options. As research continues and more treatment centers become certified to administer CAR-T therapies, patients with follicular lymphoma and other blood cancers may benefit from these life-extending innovations.

Bristol Myers’ commitment to expanding the reach and impact of its CAR-T therapies underscores the evolving landscape of cancer treatment. With ongoing efforts to enhance manufacturing capabilities and broaden therapeutic indications, the company is poised to make substantial contributions to the field of oncology, offering renewed hope for patients battling complex cancers.

Jhumpa Lahiri

Jhumpa Lahiri

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