FDA clears one‑minute subcutaneous mosunetuzumab for heavily pretreated follicular lymphoma | iPharmaCenter
- Badari Andukuri
- Jan 23
- 2 min read
The US Food and Drug Administration has authorised a new under‑the‑skin version of the CD20xCD3 bispecific antibody mosunetuzumab for adults with relapsed or refractory follicular lymphoma after two or more previous systemic treatments.
This subcutaneous regimen, known as Lunsumio VELO, received accelerated approval based on phase I/II data from the GO29781 trial, with continued approval potentially dependent on confirmation of clinical benefit in a follow‑up study.
The new formulation shortens chair time dramatically, delivering treatment via an injection lasting about one minute instead of the 2–4 hour infusion required for the intravenous product.
As with the IV schedule, subcutaneous mosunetuzumab can be given in an outpatient setting as a time‑limited course, with therapy potentially completed in roughly six months rather than continued indefinitely until progression or intolerance. This fixed‑duration approach can lessen the cumulative burden of ongoing therapy compared with regimens that continue until the disease worsens.
Regulatory clearance in the United States is supported by the primary analysis of GO29781 in patients receiving mosunetuzumab in the third line and beyond for follicular lymphoma.
In this cohort, treatment with the subcutaneous formulation produced an objective response rate of 75% and a complete response rate of 59%, with responses lasting a median of 22.4 months.
Findings from GO29781 have been shared with regulatory agencies worldwide, supporting submissions beyond the United States. Recently, the European Commission granted conditional approval for subcutaneous mosunetuzumab in adults with relapsed or refractory follicular lymphoma after at least two prior systemic therapies.
The GO29781 study is a multicentre, open‑label, phase I/II dose‑escalation and expansion trial assessing safety, antitumour activity and pharmacokinetics of mosunetuzumab delivered both intravenously and subcutaneously in people with relapsed or refractory B‑cell non‑Hodgkin lymphoma. For the subcutaneous regimen, efficacy was determined primarily by overall response rate and durability of response.
Follicular lymphoma is the most common indolent subtype of non‑Hodgkin lymphoma, representing roughly one‑fifth of all cases. It generally responds to initial therapy but is marked by repeated periods of remission and relapse, and each subsequent recurrence tends to be more difficult to control, with early relapse linked to poorer long‑term outcomes. Globally, more than 110,000 people are estimated to be diagnosed with this disease every year.
Mosunetuzumab is a T‑cell‑engaging bispecific antibody engineered to bind CD20 on B cells and CD3 on T cells. By bringing T cells into close contact with malignant B cells, the drug stimulates T‑cell activation and directs the release of cytotoxic molecules that kill the targeted lymphoma cells.
The subcutaneous Lunsumio VELO formulation is being explored both as monotherapy and in combinations for a range of B‑cell non‑Hodgkin lymphomas, including follicular lymphoma, large B‑cell lymphoma and additional settings.
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