(Lymphoma) FDA Approves Brukinsa for Waldenström's Macroglobulinemia

• September 7, 2021
• 1 min read

On August 31, 2021, the U.S. Food and Drug Administration (FDA) approved Brukinsa (zanubrutinib) for the treatment of Waldenström's macroglobulinemia (WM).

This approval was based on the ASPEN clinical trial (NCT03053440), a randomized, active-controlled, open-label study in patients with WM harboring MYD88 L265P mutation, divided into two cohorts. Cohort 1 patients (n=201) were randomized 1:1 to Brukinsa (160 mg twice daily) or ibrutinib (420 mg once daily) until disease progression or intolerable adverse effects. Cohort 2 enrolled patients with wild-type MYD88, or unknown MYD88 mutation status (n=26 and n=2, respectively), and received Brukinsa (160 mg twice daily).

The efficacy data supporting this approval were based on criteria established at the 6th International Workshop on Waldenström's Macroglobulinemia, which incorporated response assessments above IRC thresholds and included duration of response as an additional efficacy endpoint.

Results:

In Cohort 1, the Brukinsa arm achieved an objective response rate (ORR) of 77.5% and a 12-month duration of response rate of 94.4%. In Cohort 2, the ORR was 50%.

Safety:

The most common adverse reactions (including laboratory abnormalities, ≥20%) in the Brukinsa arm included neutropenia, upper respiratory tract infection, thrombocytopenia, rash, hemorrhage, musculoskeletal pain, decreased hemoglobin, bruising, diarrhea, pneumonia, and cough.

Recommended dosing: Brukinsa 160 mg orally twice daily or 320 mg once daily.

Source: https://www.cancerit.jp/70053.html

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