Genentech bags Lunsumio FDA approval for R/R follicular lymphoma

Lunsumio FDA approval : Genentech, a subsidiary of the Roche Group, has secured the approval of the US Food and Drug Administration (FDA) for Lunsumio (mosunetuzumab-axgb) for the treatment of relapsed or refractory (R/R) follicular lymphoma (FL) in adults, subjected to two or more treatments for their cancer.

Lunsumio is a CD20xCD3 T-cell engaging bispecific antibody designed to treat the slow-growing form of non-Hodgkin’s lymphoma.

Administered as a fixed-duration treatment, Lunsumio can be infused in an outpatient setting.

Elizabeth Budde — Lunsumio clinical trial investigator, commenting on Lunsumio FDA approval, said: “As a first-in-class T-cell engaging bispecific antibody that can be initiated in an outpatient setting, Lunsumio’s high response rates and fixed-duration could change the way advanced follicular lymphoma is treated.”

The FDA approval was backed by the findings of the GO29781 phase 2 study in which people with relapsed or refractory B-cell non-Hodgkin’s lymphoma showed that 80% of patients who received at least two prior therapies achieved durable response rates, with 60% experiencing complete remission.

Genentech bags Lunsumio FDA approval for the treatment of R/R follicular lymphoma. Photo courtesy of F. Hoffmann-La Roche Ltd.

Commenting on Lunsumio FDA approval, Dr. Lee Greenberger — Leukemia & Lymphoma Society chief scientific officer, said: “This additional treatment option is good news for people whose blood cancer has not responded to multiple lines of treatment because it can become more difficult to treat each time it returns.

“This bispecific antibody is an off-the-shelf, accessible treatment option that has the potential to help those with relapsed or refractory follicular lymphoma achieve remission.”

Lunsumio is being further investigated as a subcutaneous formulation and as a treatment for people with non-Hodgkin’s lymphoma in phase 3 studies.

Approved under accelerated approval based on response rate, the continued approval of Lunsumio for this indication may be conditional on verification and description of clinical benefit in ongoing studies.

Genentech-discovered and developed Lunsumio will be available in the US in the coming weeks, according to the company.

It is projected that over 100,000 people are diagnosed with follicular lymphoma per annum around the world.