BMS’ cancer drug Breyanzi set for another approval
US pharma major Bristol Myers Squibb (NYSE: BMY) has announced that the Phase II TRANSCEND FL trial evaluating Breyanzi (lisocabtagene maraleucel) in adult patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma met its primary endpoint in the marginal zone lymphoma (MZL) cohort.
Results showed that Breyanzi demonstrated a statistically-significant and clinically-meaningful overall response rate (ORR) in these patients, suggesting the drug could add a new indication to its currently approved uses. However, BMS’s shares were down 2.3% at $55.50 by late morning on Monday.
BMS noted that the study also met the key secondary endpoint of complete response rate (CRR). In the top-line analysis, Breyanzi continued to demonstrate durable responses and a consistent safety profile with no new safety signals observed.
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