Bristol Myers Squibb (BMS) has received accelerated approval from the FDA for its one-time CAR T therapy, Breyanzi, for adult patients with relapsed or refractory follicular lymphoma. Breyanzi is used on patients with at least two previous systemic therapies.
According to BMS, Breyanzi demonstrates a significant overall response rate of 95.7% and a complete response rate of 73.4%. The drug has also showcased a consistent safety profile throughout the trials, providing potential for lasting remission with a one-time infusion and safety profile for administration and monitoring in the inpatient and outpatient setting.
Breyanzi is approved in the US for treating relapsed or refractory large B-cell lymphoma (LBCL), with accelerated approval for chronic lymphocytic leukemia or small lymphocytic lymphoma after prior therapies. It's also approved in Japan, the EU, and Switzerland for different stages of LBCL treatment, including second-line and multiple relapse scenarios.
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