FDA grants Priority Review to Roche ’s Lunsumio for people with relapsed or refractory follicular lymphoma

Lunsumio® (mosunetuzumab) could be the first CD20xCD3 T-cell engaging bispecific antibody approved by the FDA for the treatment of any type of non-Hodgkin lymphomaApplication is based on results from the pivotal phase I/II study showingLunsumio induced high and durable complete response rates in people with follicular lymphoma who received two or more prior therapiesLunsumio is a fixed-duration treatment option with the potential to be administered in an outpatient settingBasel, 6 July 2022 - 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 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 sy stemic therapies. FL is the most common indolent (slow growing) form of non-Hodgkin lymphoma (NHL), a type of blood cancer, which often returns after initial therapy. The FDA is expected to make a decision on approval of this novel cancer immunotherapy by 29 December 2022.“New therapeutic options are needed for follicular lymphoma, which often relapses after initial therapy and becomes increasingly difficult to treat each time it returns. Clinical trial results have demonstrated durable responses with Lunsumio in advanced follicular lymphoma, representing a step to w...
Source: Roche Media News - Category: Pharmaceuticals Source Type: news