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

發(fā)布時(shí)間： 2022-07-15 閱讀：454次

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July 10, 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 systemic 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 toward shifting the treatment paradigm,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Since Lunsumio does not require the collection or genetic modification of patient cells, it could become an effective, fixed-duration outpatient option without the barriers of travelling to a major academic centre.”