FDA approves mosunetuzumab's subcutaneous formulation, enhancing treatment access for relapsed follicular lymphoma.
The FDA has approved a subcutaneous (SC) formulation of mosunetuzumab (Lunsumio VELO; Genentech/Roche) for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after 2 or more lines of systemic therapy. Mosunetuzumab is a CD20xCD3 T-cell engaging bispecific antibody.
While the intravenous (IV) formulation required 2- to 4-hour infusions, the SC formulation offers a fixed-duration, approximately 1-minute injection. The IV formulation was first approved 3 years earlier in December 2022.2 This transition to an SC formulation represents a significant shift in the delivery of bispecific antibodies, potentially moving administration from specialized infusion centers to broader community pharmacy and outpatient settings.
“This approval is a significant step in broadening access to effective treatments for people living with follicular lymphoma,” Ian Flinn, MD, PhD, hematologist with Tennessee Oncology and chief scientific officer of OneOncology, said in a statement.1 “With its manageable cytokine release syndrome profile and reduced administration time, Lunsumio VELO enables oncologists to deliver advanced care in community practice settings.”
Administration time: 2-4 hours for IV vs approximately 1 minute for SC
Dosing schedule: Cycle 1 step-up; fixed duration for both
Treatment window: 8-17 cycles (approximately 6-12 months) for both
Setting: Infusion center or hospital for IV vs outpatient or community clinic for SC
The approval is supported by the phase 1/2 GO29781 trial, which utilized a pharmacokinetic noninferiority design. SC delivery achieved exposure levels comparable with the IV route, ensuring therapeutic efficacy is maintained despite the change in delivery volume and absorption kinetics.
The overall response rate was 74.5% (95% CI, 64.4%-82.9%), and the complete response (CR) rate was 58.5% (95% CI, 46.9%-68.6%). The median duration of CR was 20.8 months.
Injection site reactions were the most common adverse event (60.6%) due to the SC administration, though they were generally mild. Another common adverse event was fatigue, which occurred in 35.1% of patients.
The primary safety concern remains cytokine release syndrome (CRS). In the SC cohort, CRS occurred in 29.8% of patients.
Pharmacists should ensure that appropriate premedications (eg, corticosteroids, antipyretics, and antihistamines) are administered according to the prescribing information, particularly during the first cycle.
The shift to a 1-minute SC injection provides several advantages:
“Since follicular lymphoma often requires lifelong management, reducing the burden of care for these individuals is of paramount importance,” said Levi Garraway, MD, PhD, Roche’s chief medical officer and head of global product development.1 “With this FDA approval, treatment can now be administered in just one minute, which significantly reduces the time patients spend in the clinic and helps to align care with their individual needs and preferences.”
Mosunetuzumab is being studied in combination with lenalidomide (Revlimid; Bristol Myers Squibb) for previously untreated FL (NCT04792502), and as either a monotherapy or in combination with zanubrutinib (Brukinsa; BeOne Medicines) for patients with newly diagnosed FL who need systemic therapy (NCT05389293).
In diffuse large B-cell lymphoma, mosunetuzumab plus polatuzumab vedotin (Polivy; Roche) is being evaluated in the second-line setting (NCT05171647). The bispecific is also being researched as a monotherapy or in combination with venetoclax (Venclexta; AbbVie, Roche) or atezolizumab (Tecentriq; Roche) for relapsed or refractory chronic lymphocytic leukemia (NCT05091424). There is also a trial comparing mosunetuzumab with rituximab (Rituxan; Roche, Biogen) in patients with nodular lymphocyte-predominate Hodgkin lymphoma (NCT05886036).
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