On September 14, 2021, the FDA accelerated the approval of Brukinsa (zanubrutinib; from BeiGene) oral capsules for the treatment of adults with relapsed (coming back) or refractory (not responding to therapy) marginal-zone lymphoma (MZL) who have received 1 or more anti-CD20–based regimens.
Two weeks earlier, on August 31, 2021, the FDA accelerated the approval of Brukinsa for adults with Waldenström’s macroglobulinemia (WM), a rare, slow-growing type of non-Hodgkin lymphoma. Brukinsa was previously approved for mantle-cell lymphoma.
The approval of Brukinsa for MZL was based on 2 clinical trials that together included 86 patients who had previously received treatment for MZL.
The response rate to Brukinsa was 56% in the first study, including 20% complete responses (meaning that there was no evidence of cancer). In the second study, the response rate was 80%, including 20% complete responses. The average length of response to treatment was not estimable, because patients were still responding to Brukinsa.
The approval of Brukinsa for WM was based on 2 patient groups in the ASPEN study of patients with WM. Group 1 included 201 patients with WM and MYD88 L265P mutation, and group 2 included 26 patients with WM but without the mutation. The response rate to Brukinsa in group 1 was 77.5%, and most of these patients (94.4%) had an event-free response lasting at least 12 months. In group 2, of the 26 patients without the mutation, 50% had a response to Brukinsa, including complete and partial responses.
The most common side effects reported with Brukinsa are changes in some blood chemistry levels, upper-respiratory tract infection, rash, bleeding, musculoskeletal pain, bruising, diarrhea, pneumonia, and cough.
