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The FDA has granted accelerated approval for a subcutaneous (SC) formulation of mosunetuzumab (Lunsumio VELO, Roche) for the treatment of certain adults with relapsed or refractory follicular lymphoma.
Specifically, the CD20 × CD3 bispecific antibody — which was initially approved as an intravenous (IV) formulation and was the first of its kind approved for relapsed or refractory follicular lymphoma after at least 2 prior lines of therapy — is now approved for SC administration in the same setting, according to a Roche press release.
SC delivery reduces treatment time to about 1 minute compared with the 2–4 hours required with IV infusion. Like the IV formulation, the SC version can be administered in the outpatient setting and is a fixed-duration treatment given for a defined period, Roche noted, adding that “[b]y contrast, treat-to-progression treatment options are designed to be given to patients indefinitely until disease progression or until treatment can no longer be tolerated.”
Full approval, which may be contingent on verification of benefit in a confirmatory trial, was based on findings from the phase 1/2 G029781 study of both IV and SC formulations in patients with relapsed or refractory non–Hodgkin lymphoma, including follicular lymphoma.
The objective response rate and complete response rate with SC formulation were 75% and 59%, respectively. The median duration of response was 22.4 months.
Adverse reactions occurring in at least 20% of patients were injection site reactions, fatigue, rash, cytokine release syndrome (CRS), SARS–CoV–2 infection, musculoskeletal pain, and diarrhea. CRS occurred in 30% of patients. Most of those events were low-grade, and all resolved after a median of 2 days.
“This approval is a significant step in broadening access to effective treatments for people living with follicular lymphoma,” stated Ian Flinn, MD, PhD, of Tennessee Oncology and OneOncology. “With its manageable cytokine release syndrome profile and reduced administration time, Lunsumio VELO enables oncologists to deliver advanced care in community practice settings.”
A version of this article first appeared on Medscape.com.
The FDA has granted accelerated approval for a subcutaneous (SC) formulation of mosunetuzumab (Lunsumio VELO, Roche) for the treatment of certain adults with relapsed or refractory follicular lymphoma.
Specifically, the CD20 × CD3 bispecific antibody — which was initially approved as an intravenous (IV) formulation and was the first of its kind approved for relapsed or refractory follicular lymphoma after at least 2 prior lines of therapy — is now approved for SC administration in the same setting, according to a Roche press release.
SC delivery reduces treatment time to about 1 minute compared with the 2–4 hours required with IV infusion. Like the IV formulation, the SC version can be administered in the outpatient setting and is a fixed-duration treatment given for a defined period, Roche noted, adding that “[b]y contrast, treat-to-progression treatment options are designed to be given to patients indefinitely until disease progression or until treatment can no longer be tolerated.”
Full approval, which may be contingent on verification of benefit in a confirmatory trial, was based on findings from the phase 1/2 G029781 study of both IV and SC formulations in patients with relapsed or refractory non–Hodgkin lymphoma, including follicular lymphoma.
The objective response rate and complete response rate with SC formulation were 75% and 59%, respectively. The median duration of response was 22.4 months.
Adverse reactions occurring in at least 20% of patients were injection site reactions, fatigue, rash, cytokine release syndrome (CRS), SARS–CoV–2 infection, musculoskeletal pain, and diarrhea. CRS occurred in 30% of patients. Most of those events were low-grade, and all resolved after a median of 2 days.
“This approval is a significant step in broadening access to effective treatments for people living with follicular lymphoma,” stated Ian Flinn, MD, PhD, of Tennessee Oncology and OneOncology. “With its manageable cytokine release syndrome profile and reduced administration time, Lunsumio VELO enables oncologists to deliver advanced care in community practice settings.”
A version of this article first appeared on Medscape.com.
The FDA has granted accelerated approval for a subcutaneous (SC) formulation of mosunetuzumab (Lunsumio VELO, Roche) for the treatment of certain adults with relapsed or refractory follicular lymphoma.
Specifically, the CD20 × CD3 bispecific antibody — which was initially approved as an intravenous (IV) formulation and was the first of its kind approved for relapsed or refractory follicular lymphoma after at least 2 prior lines of therapy — is now approved for SC administration in the same setting, according to a Roche press release.
SC delivery reduces treatment time to about 1 minute compared with the 2–4 hours required with IV infusion. Like the IV formulation, the SC version can be administered in the outpatient setting and is a fixed-duration treatment given for a defined period, Roche noted, adding that “[b]y contrast, treat-to-progression treatment options are designed to be given to patients indefinitely until disease progression or until treatment can no longer be tolerated.”
Full approval, which may be contingent on verification of benefit in a confirmatory trial, was based on findings from the phase 1/2 G029781 study of both IV and SC formulations in patients with relapsed or refractory non–Hodgkin lymphoma, including follicular lymphoma.
The objective response rate and complete response rate with SC formulation were 75% and 59%, respectively. The median duration of response was 22.4 months.
Adverse reactions occurring in at least 20% of patients were injection site reactions, fatigue, rash, cytokine release syndrome (CRS), SARS–CoV–2 infection, musculoskeletal pain, and diarrhea. CRS occurred in 30% of patients. Most of those events were low-grade, and all resolved after a median of 2 days.
“This approval is a significant step in broadening access to effective treatments for people living with follicular lymphoma,” stated Ian Flinn, MD, PhD, of Tennessee Oncology and OneOncology. “With its manageable cytokine release syndrome profile and reduced administration time, Lunsumio VELO enables oncologists to deliver advanced care in community practice settings.”
A version of this article first appeared on Medscape.com.