FDA accepts Roche's Lunsumio BLA for priority review

Shares of Swiss pharma giant Roche (ROG: SIX) edged up 2% to 325.35 francs this morning, after it announced that the US Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) and granted Priority Review for Lunsumio (mosunetuzumab), a potential first-in-class CD20xCD3 T-cell engaging bispecific antibody, for the treatment of adults with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two prior systemic therapies.

The European Commission granted conditional marketing authorization for Lunsumio last month for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two prior systemic therapies.

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