FDA accepts BLAs from Roche and UCB for priority review

6 January 2023

The US Food and Drug Administration (FDA) yesterday accepted Biologics License Applications (BLAs) from Swiss pharma giant Roche (ROG: SIX) and Belgium’s UCB (Euronext: UCB), and granted them accelerated review.

First up, the FDA granted priority review for Roche’s glofitamab, an investigational CD20xCD3 T-cell engaging bispecific antibody, for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) after two or more lines of systemic therapy. LBCL is an aggressive (fast-growing) type of non-Hodgkin lymphoma (NHL) and is one of the most prevalent types of blood cancer among adults in the USA.

The FDA is expected to make a decision on approval of this novel cancer immunotherapy by July 1, 2023. If approved, glofitamab would be the first fixed-duration, off-the-shelf CD20xCD3 T-cell engaging bispecific antibody available to treat people with an aggressive lymphoma who have previously received multiple courses of treatment.

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