FDA Gives Accelerated Approval to Pirtobrutinib in CLL/SLL

The designation was based on findings from the phase 1/2 BRUIN study (NCT03740529), which included a total of 108 patients with CLL/SLL who had undergone treatment with a median of 5 prior lines of therapy.

The News

The FDA has granted accelerated approval to pirtobrutinib as a treatment for patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) who have undergone prior treatment with at least 2 lines of therapy including a BTK and BCL-2 inhibitor, according to a press release from the FDA.

The Design

The designation was based on findings from the phase 1/2 BRUIN study (NCT03740529), which included a total of 108 patients with CLL/SLL who had undergone treatment with a median of 5 prior lines of therapy. In total, 77% of patients had refractory or progressive CLL/SLL. The population received pirtobrutinib at a dose of 200 mg orally once daily. Treatment continued until disease progression or unacceptable toxicity.

The Efficacy

Patients treated with the agent achieved an overall response rate of 72% (95% CI, 63%-80%), with all responses being partial. The median duration of response was 12.2 months (95% CI, 9.3-14.7).

The Safety

Frequent adverse effects from the trial included fatigue, bruising, cough, musculoskeletal pain, COVID-19, diarrhea, pneumonia, abdominal pain, dyspnea, hemorrhage, edema, nausea, pyrexia, and headache. Additionally, high-grade laboratory abnormalities included decreased neutrophil count, anemia, and decreased platelet count. A total of 32% of patients developed a serious infection, 10% of which were fatal.

Reference

FDA grants accelerated approval to pirtobrutinib for chronic lymphocytic leukemia and small lymphocytic lymphoma. News release. FDA. December 1, 2023. Accessed December 1, 2023. https://bit.ly/48011OO