FDA Approves Zanubritinib for the Treatment of Waldenström’s Macroglobulinemia

The FDA has approved zanubritinib (Brukinsa, BeiGene) for the treatment of adult patients with Waldenström’s macroglobulinemia (WM).

“With 11 regulatory approvals in under 2 years, including 2 in the US, Brukinsa is demonstrating its growing utility as a treatment option for B-cell malignancies and expanding its footprint to potentially benefit more patients worldwide,” said Jane Huang, MD, BeiGene’s chief medical officer, Hematology, in a press release. “We will continue to evaluate Brukinsa in its broad global clinical program and look forward to additional clinical evidence to establish its position as a potentially best-in-class medicine.”

Zanubritinib is a monotherapy treatment that is used in combination with other therapies to treat various B-cell malignancies. It was designed to deliver complete and sustained inhibition of the Bruton’s tyrosine kinase (BTK) protein. The treatment has been approved for mantle cell lymphoma, chronic lymphocytic leukemia, WM, and other disease states.

“The approval of Brukinsa in Waldenström’s macroglobulinemia, which is the second therapy approved specifically for the treatment of this rare type of lymphoma, is positive news for patients,” said Pete DeNardis, the International Waldenström’s Macroglobulinemia Foundation’s chair of the board, in the press release. “Expanded treatment options offer new hope for those living with this disease and can potentially improve patient experience, especially oral therapies that can be given as a single agent.”

The results from the ASPEN trial showed that the response rate for patients treated with zanubritinib was 28%, while with ibrutinib, a similar drug, patients had a response rate of 19%, based on the Sixth International Workshop on WM response criteria.

The recommended dose for zanubritinib in patients with WM is either 160 mg twice a day or 320 mg once a day; however, the dose may be adjusted for adverse reactions and reduced for individuals who experience certain drug interactions or severe hepatic impairment.

“The ASPEN trial provided compelling evidence that Brukinsa is a highly active BTK inhibitor in Waldenström’s macroglobulinemia, and compared to the first-generation BTK inhibitor, showed improved tolerability across a number of clinically important side effects,” said Steven Treon, MD, PhD, director of the Bing Center for Waldenström’s Macroglobulinemia Research at the Dana-Farber Cancer Institute and professor of medicine at Harvard Medical School, in the press release. “The approval of Brukinsa provides an important new option for targeted therapy in Waldenström’s macroglobulinemia.”

Reference

US FDA grants BRUKINSA(zanubrutinib) approval in Waldenström’s macroglobulinemia. Businesswire. News release. September 1, 2021. Accessed September 1, 2021. https://www.businesswire.com/news/home/20210901006049/en