On Friday, the European Fee (EC) authorised Bristol Myers Squibb & Co‘s BMY Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell remedy, for grownup sufferers with relapsed or refractory follicular lymphoma (FL) after two or extra strains of systemic remedy.
The choice relies on world Part 2 TRANSCEND FL research outcomes.
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Amongst sufferers handled within the third-line plus setting, Breyanzi demonstrated a excessive general response fee of 97.1% and a whole response (CR) fee of 94.2%, the research’s main and key secondary endpoints, respectively.
Responses have been fast, sturdy, and demonstrated sustained efficacy, with a median time to first response of 0.95 months and 75.7% of sufferers nonetheless in response at 18 months.
Final March, the FDA granted accelerated approval to Breyanzi for relapsed or refractory persistent lymphocytic leukemia or small lymphocytic lymphoma.
In Might, the FDA granted accelerated approval to Breyanzi for relapsed or refractory follicular lymphoma.
In November, Bristol Myers Squibb shared preliminary information from a Part 1 research of CC-97540 (BMS-986353), a CD19-directed CAR T Cell Remedy Manufactured Utilizing a Subsequent-generation Course of for extreme, refractory autoimmune illnesses.
Worth Motion: BMY inventory is down 1.92% at $59.13 on the final verify Friday.
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Picture: Courtesy of Bristol Myers Squibb
Momentum86.33
Progress36.93
High quality–
Worth14.12
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