ASCO: BMS pitches Breyanzi as the first CAR-T for CLL. But will a single-arm trial persuade the FDA?

In new data released Thursday, Bristol Myers Squibb said that Breyanzi eradicated signs of cancer in 18.4% of patients with heavily pretreated CLL or small lymphocytic lymphoma (SLL). The phase 1/2 trial coded TRANSCEND CLL 004 has therefore met its primary endpoint.