Dr. Rule on the FDA Approval of Zanubrutinib in MCL

Simon Rule, MD, PhD
Published: Friday, Nov 15, 2019



Simon Rule, MD, PhD, professor of hematology, Plymouth University Medical School, United Kingdom, discusses the FDA approval of zanubrutinib (Brukinsa) in mantle cell lymphoma (MCL).

The FDA granted an accelerated approval to zanubrutinib for patients with MCL who received at least 1 prior therapy, joining ibrutinib (Imbruvica) and acalabrutinib (Calquence) in this indication. The approval is based on findings from two single-arm studies. In the phase II BGB-3111-206 trial, which was conducted in China, the objective response rate (ORR) was 84%, and the complete response (CR) rate was 59% in patients who had received 1 to 4 prior lines of therapy. At a median follow-up of 18.4 months, the median duration of response (DOR) was 19.5 months. In the phase I/II BGB-3111-AU-003 trial, updated findings showed that of 32 patients, ORR was 84%, and the CR rate was 22%. At a median follow-up of 18.8 months, the median DOR was 18.5 months.

Having used 5 BTK inhibitors in MCL, Rule states that they are all effective. Though, there are toxicity differences. It’s encouraging to see more BTK inhibitors enter the space for patients and practitioners alike, explains Rule. Additionally, the approvals of these agents could lead to increased competition, lower pricing, and ultimately greater access, he concludes.
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Simon Rule, MD, PhD, professor of hematology, Plymouth University Medical School, United Kingdom, discusses the FDA approval of zanubrutinib (Brukinsa) in mantle cell lymphoma (MCL).

The FDA granted an accelerated approval to zanubrutinib for patients with MCL who received at least 1 prior therapy, joining ibrutinib (Imbruvica) and acalabrutinib (Calquence) in this indication. The approval is based on findings from two single-arm studies. In the phase II BGB-3111-206 trial, which was conducted in China, the objective response rate (ORR) was 84%, and the complete response (CR) rate was 59% in patients who had received 1 to 4 prior lines of therapy. At a median follow-up of 18.4 months, the median duration of response (DOR) was 19.5 months. In the phase I/II BGB-3111-AU-003 trial, updated findings showed that of 32 patients, ORR was 84%, and the CR rate was 22%. At a median follow-up of 18.8 months, the median DOR was 18.5 months.

Having used 5 BTK inhibitors in MCL, Rule states that they are all effective. Though, there are toxicity differences. It’s encouraging to see more BTK inhibitors enter the space for patients and practitioners alike, explains Rule. Additionally, the approvals of these agents could lead to increased competition, lower pricing, and ultimately greater access, he concludes.

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