Up­dat­ed: FDA clears first CD20xCD3 bis­pe­cif­ic, giv­ing Genen­tech leg up in a crowd­ed lym­phoma R&D field

The first CD20xCD3 bis­pe­cif­ic an­ti­body will soon be­come avail­able in the US fol­low­ing an FDA ap­proval dis­closed Thurs­day night, Dec. 22.

Roche and Genen­tech’s mo­sune­tuzum­ab was green­lit as a third-line treat­ment for adults with re­lapsed or re­frac­to­ry fol­lic­u­lar lym­phoma. FDA’s ac­cel­er­at­ed ap­proval of the ther­a­py now brand­ed as Lun­sumio comes sev­en days ear­ly and fol­lows suit be­hind the Eu­ro­pean Union, which cleared the drug on June 3, 2022.

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