Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on a recent FDA cancer drug approval.
On December 22, 2022, the FDA granted accelerated approval to mosunetuzumab-axgb (brand name Lunsumio), a bispecific CD20-directed CD3 T-cell engager for adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
Mosunetuzumab-axgb was evaluated in GO29781, an open-label, multicenter, multi-cohort study. The efficacy population consisted of 90 patients with relapsed or refractory follicular lymphoma who had received at least two prior lines of systemic therapy, including an anti-CD20 monoclonal antibody and an alkylating agent.
The main efficacy outcome measure was objective response rate assessed by an independent review facility according to standard criteria for non-Hodgkin’s lymphoma. The objective response rate was 80%, with 60% achieving complete responses. With a median follow-up of 14.9 months among responders, the estimated median duration of response was 22.8 months and the estimated duration of response rate at 12 months and 18 months was 62% and 57%, respectively.
The prescribing information has a Boxed Warning for serious or life-threatening cytokine release syndrome. Warnings and precautions include neurologic toxicity, infections, cytopenias, and tumor flare. Among 218 patients with hematologic malignancies who received mosunetuzumab-axgb at the recommended dose, cytokine release syndrome occurred in 39% of patients, neurologic toxicity in 39%, serious infections in 17%, and tumor flare in 4%. For cytokine release syndrome, Grade 2 occurred in 15%, Grade 3 in 2%, and Grade 4 in 0.5%.
This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.
Full prescribing information for these approvals can be found at Drugs@FDA: FDA-Approved Drugs.
Health care professionals should report serious adverse events to FDA’s MedWatch Reporting Program at MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
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