FDA Greenlights BeiGene’s Brukinsa for Waldenstrom’s Macroglobulinemia

The U.S. Food and Drug Administration (FDA) approved BeiGene’s Brukinsa (zanubrutinib) for adults with Waldenstrom’s macroglobulinemia (WM). Brukinsa is a Bruton’s tyrosine kinase (BTK) inhibitor that is approved for mantle cell lymphoma and chronic lymphocytic leukemia.

“We are delighted by today’s FDA approval for Brukinsa in its second indication, offering a new treatment option with demonstrated efficacy and safety benefits for patients with Waldenstrom’s macroglobulinemia,” said Jane Huang, Chief Medical Officer, Hematology at BeiGene. “As shown in the ASPEN trial, Brukinsa can improve treatment outcomes for these patients and potentially make a positive impact on their lives.”

The approval was built on data from the Phase III ASPEN trial that compared Brukinsa to ibrutinib (Janssen and Pharmacyclic’s Imbruvica) in a total of 201 patients with MYD88 mutation. The primary efficacy endpoint was very good partial response (VGPR) in the overall intention-to-treat (ITT) population as evaluated by the independent review committee (IRC). The VGPR rate was 28% with Brukinsa compared to 19% with Imbruvica based on the modified Sixth International Workshop on Waldenstrom’s Macroglobulinemia (IWWM-6).

To Read the Complete Article at BioSpace Click Here

Disclaimer: BioPharma Global is not responsible for, and expressly disclaims all liability for, damages of any kind arising out of use, reference to, or reliance on any information contained within the article. Content available through the site may contain links and information to other websites. Links from BioPharma Global to third-party sites do not constitute an endorsement by BioPharma Global of the mentioned parties.

BioPharma Global is a mission-driven corporation, operating like a not-for-profit, dedicated to using our FDA and EMA regulatory expertise and knowledge of various therapeutic areas to help drug developers advance treatments for the disease communities with a high unmet medical need. If you are a drug developer seeking regulatory support for Orphan Drug designation, Fast Track designation, Breakthrough Therapy designation, other FDA/EMA expedited programs, type A, B (pre-IND, EOPs), or C meeting assistance, or IND filings, the BioPharma Global team can help. Contact us today to arrange a 30-minute introductory call.

Stock image by @Giovanni_Cancemi from Depositphotos

Add a Comment

Your email address will not be published. Required fields are marked *