FDA approval of Breyanzi offers real hope to CLL and SLL patients!
I’ve got to say I’m very, very pleased for BMS for the 15-May-2024 FDA approval of their CAR-T drug Breyanzi for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least two prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor. Definitely one to celebrate and put them on a steady keel as all approved CAR-T therapies have had a challenging start to the year. The FDA approval is an accelerated approval based on response rate and duration of response results from the single-arm TRANSCEND-FL study (NCT04245839). Why is this important? CLL and SLL patients often experience relapse or become refractory following early-line treatment with BTK and BCL-2 inhibitors. After relapsing or becoming refractory to these therapies, patients have few options and poor outcomes, including lack of durable complete responses (CR). There simply is no established standard of care for patients with double-class exposed CLL or SLL. It looks grim and it really is the last-chance saloon scenario, isn’t it? Till now. With a one-time infusion, albeit with the ever-present danger of CRS, CLL and SLL patients can have renewed hope. The CR rate associated with the Breyanzi treatment was 20%, but(!!!!) high rates of minimal residual disease (MRD) negative status were observed across patients treated with Breyanzi who achieved a CR, with an MRD-negativity rate of 100% in the blood and 92.3% in the bone marrow. So yes, we might be able to call that a cure with a high expectation of durability – but let’s see how the long-term data pans out. All in all, this is impressive and it is a realistic and pragmatic assessment. Most of all, I’m really pleased for the CLL and SLL patients. Renewed HOPE 👍.