FDA grants priority review to Roche ’s bispecific antibody glofitamab for people with relapsed or refractory large B-cell lymphoma

If approved,glofitamab would be the first fixed-duration CD20xCD3 T-cell engaging bispecific antibody approved to treat the most aggressive type of non-Hodgkin lymphomaResults from the pivotal phase I/II NP30179 study showedglofitamab induced durable response rates in people with heavily pre-treated large B-cell lymphoma, with 40% achieving a complete responseGlofitamab is part of Roche ’s industry-leading portfolio of T-cell engaging bispecific antibodies, which also includes the newly FDA-approved first-in-classLunsumio to treat follicular lymphomaBasel, 6 January 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company ’s Biologics License Application (BLA) and granted priority review for 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 i s 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 U.S.1 The FDA is expected to make a decision on approval of this novel cancer immunotherapy by 1 July 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.“Unfortuna...
Source: Roche Investor Update - Category: Pharmaceuticals Source Type: news