FDA approves bispecific antibody from Genentech

The FDA has approved Genentech‘s Lunsumio (mosunetuzumab-axgb), a novel bispecific antibody for relapsed or refractory follicular lymphoma (R/R FL).

The indication covers R/R FL patients who have received at least two prior systemic therapies. 

Patients with the cancer subtype have had limited treatment options and significant morbidity and mortality. 

The approval of Lunsumio is the first time the FDA has approved a bispecific antibody to treat one of the most common slow-growing forms of non-Hodgkin’s lymphoma.

Lunsumio is a CD20xCD3 T-cell-engaging bispecific antibody. 

Priority review and breakthrough therapy designation

FDA granted priority review to Lunsumio this summer. The agency granted it breakthrough therapy designation (BTD) in 2020. 

In the pivotal Phase 2 GO29781 study, 60% (54/90) of Lunsumio recipients who received at least two prior therapies had complete remission. A total of 80% (72/90) of patients had …

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Roche’s bispecific antibody Lunsumio wins priority review from FDA for non-Hodgkin lymphoma

Roche (SIX:RO, ROG; OTCQX:RHHBY) has announced that it has accepted the company’s Biologics License Application (BLA) and granted priority review for Lunsumio (mosunetuzumab), a CD20xCD3 T-cell engaging bispecific antibody developed by the company’s Genentech subsidiary.

In February, Biogen (Nasdaq:BIIB) said it would pay $30 million to exercise an option to participate in the development and commercialization of the drug candidate.

Basel, Switzerland-based Roche believes mosunetuzumab holds potential for adults with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two other systemic therapies.

Follicular lymphoma arises from B-lymphocytes and is a common slow-growing form of non-Hodgkin lymphoma (NHL).

Approximately one in five patients with follicular lymphoma relapse within two years of diagnosis, according to an article in the ASCO Post.

Lunsumio would be a fixed-duration treatment that could …

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