FDA Grants Accelerated Approval to Treatment for Marginal Zone Lymphoma, Follicular Lymphoma

The FDA has granted an accelerated approval to umbralisib for the treatment of select patients with relapsed/refractory marginal zone lymphoma (MZL) and relapsed/refractory follicular lymphoma. The agent is specifically indicated for adult patients with relapsed/refractory MZL who have previously received at least 1 anti-CD20—based regimen; it is also approved for use in adult patients with relapsed/refractory follicular lymphoma who have previously received at least 3 lines of systemic treatment.

The regulatory decision was based on data from 2 single-arm cohorts of an open-label, multicenter, multicohort trial, UTX-TGR-205 (NCT02793583), that was conducted in a total of 69 patients with MZL who had previously received at least 1 therapy, including an anti-CD20 containing regimen, and in 117 patients with follicular lymphoma who had previously received at least 2 systemic therapies. In the trial, participants received umbralisib at a once-daily dose of 800 mg until progressive disease or intolerable toxicity. Results showed that the agent elicited an ORR of 49% in patients with MZL (95% CI, 37.0, 61.6); 16% experienced complete responses (CRs). The median duration of response (DOR) had not yet been reached (95% CI, 9.3-not evaluable) in this subgroup.

For patients with follicular lymphoma, the ORR was slightly lower, at 43% (95% CI, 33.6-52.2), with 3% of patients achieving CRs. The median DOR was 11.1 months (95% CI, 8.3-16.4) in this subgroup. Regarding safety, the most frequently reported toxicities with umbralisib included increased creatinine, diarrhea/colitis, fatigue, nausea, neutropenia, transaminase elevation, musculoskeletal pain, anemia, thrombocytopenia, upper-respiratory tract infection, vomiting, abdominal pain, reduced appetite, and rash.

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