FDA Approves Bristol-Myers Squibb’s B-Cell Lymphoma Treatment As Johnson & Johnson Awaits Its COVID-19 Vaccine Approval

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The US FDA has approved Bristol-Myers Squibb’s Co. (NYSE:BMY) CAR T drug liso cel, Breyanzi in the treatment of certain B-Cell lymphomas in patients that have relapsed or have not responded to two other systemic treatments.

Breyanzi approved for the treatment of B-cell lymphoma

Bristol Myers will market the chimeric antigen receptor therapy, which is the third gene therapy to receive FDA approval for treatment of some non-Hodgkin lymphoma types, including diffuse large B-cell lymphoma. Like most CAR T treatments, Breyanzi doses are personalized and they are created from a patient’s T cells gotten from the patient and then modified genetically before they are infused into patients to kill lymphoma cells. Interestingly, the drug has not been indicated for treating primary central nervous system lymphoma patients.

The FDA’s Centre for Biologics Evaluation and Research director, Peter Marks, said that the approval represents a massive milestone in the quickly growing gene therapy field. It offers another treatment alternative to patients with specific cancer types that affect the lymph nodes, bone marrow, and blood. Marks said that cell and gene therapies have emerged from promising concepts and became practical cancer treatments.

Bristol Myers established Breyanzi’s safety and efficacy through a multicentre clinical study of 250 adult patients with refractory or relapsed large B-cell lymphoma. Around 54% of the patients that received the CAR T therapy attained complete remission. Most importantly, there is a warning label regarding the drug for cytokine release syndrome that can be severe. Due to these safety risks, the FDA requires centers administering the drug to have accreditation showing that their staff have the training and can notice side effects easily.

The company’s CEO, Chris Boerner, said in a conference early in the week that they expect the chance to launch Breynazi immediately. He stated that Bristol Myers looks focused on ensuring quick activation of sites that efficiently got patients through therapy. Also, the company plans to drive referrals for the drug and expand the sites administering it.

Johnson & Johnson releases its COVID-19 vaccines study data

Although Johnson & Johnson (NYSE:JNJ) announced strong clinical study results for its single-dose COVID-19 vaccine last week, it will be a while before the drug gets approval in the US. JNJ took six days to break down the top-line data into fine details required by the FDA. Although the released results are vital, the FDA usually requires patient-level details on those that contracted COVID19 and when it happened compared to the inoculation. Equally, the agency requires a breakdown of all adverse events as well as manufacturing data.

Considering what is required to submit an application, the company managing to do so in a week is a huge accomplishment. However, the FDA will take up to three weeks to review the emergency user authorization application. The agency could complete its work on February 24, when it will post its review of the results ahead of the advisory meeting on February 26.


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