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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