EC Approves Lunsumio, Roche’s Bispecific Antibody for Follicular Lymphoma

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Roche has received approval from the European Commission for Lunsumio (mosunetuzumab), the first CD20xCD3 T-cell engaging bispecific antibody for treating follicular lymphoma.

On June 8, 2022, Roche announced that the European Commission (EC) has granted conditional marketing authorization for Lunsumio (mosunetuzumab), a new off-the-shelf bispecific antibody for treating the most common slow-growing form of non-Hodgkin lymphoma, follicular lymphoma (FL). According to a company press release, mosunetuzumab is the first CD20xCD3 T-cell engaging bispecific antibody on the market.

The EC approval is specifically for the treatment of adult patients with relapsed or refractory FL who have received at least two prior systemic therapies. The approval is based on positive results from a Phase I/II study where the therapy demonstrated high complete response rates. The majority of complete responders maintained responses for at least 18 months. In addition, the therapy had favorable tolerability in people with heavily pre-treated FL.

Roche also has two ongoing Phase III studies investigating mosunetuzumab plus lenalidomide in second-line plus (2L+) FL treatment and mosunetuzumab plus Polivy (polatuzumab vedotin) in 2L+ treatment of diffuse large B-cell lymphoma (DLBCL), according to the press release.

The mosunetuzumab approval is Roche’s second approval in 2022 in the European Union for a lymphoma indication. In May 2022, the company received approval for Polivy in combination with MabThera (rituximab) plus cyclophosphamide, doxorubicin, and prednisone for use in previously untreated DLBCL (1).

“We are delighted that [mosunetuzumab] is the first bispecific antibody approved in Europe for people with relapsed or refractory follicular lymphoma,” said Levi Garraway, Roche’s chief medical officer and head of Global Product Development, in the press release. “[Mosunetuzumab]’s high response rates, off-the-shelf availability, and initial outpatient administration could transform how advanced follicular lymphoma is treated.”


“Having additional treatment options for people with follicular lymphoma, where multiple prior lines of therapy have failed, is critical to help them achieve better outcomes,” said Elizabeth Budde, haematologic oncologist and associate professor at City of Hope, a United States-based non-profit cancer center, in the press release. “It is exciting to have a new class of immunotherapy like [mosunetuzumab], offering a readily available, chemotherapy-free, and fixed-duration treatment, with great potential to provide durable remissions without the need to stay on treatment continuously.”


1. Roche, “Roche’s Polivy Combination Approved by European Commission for People with Previously Untreated Diffuse Large B-Cell Lymphoma,” Press Release, May 25, 2022.

Source: Roche