The first-in-class drug – which targets CD20 and CD3 – is being assessed by the regulator for relapsed or refractory FL, the most common slow-growing form of non-Hodgkin lymphoma (NHL), after two or more prior systemic therapies.
Lunsumio (mosunetuzumab) has already been approved in the EU for that indication based on the results of a phase 1/2 study which showed an overall response rate of 80% and a median progression-free survival of around 18 months when used as a third-line or later therapy.
If approved by the FDA, the drug could provide an off-the-shelf alternative to CAR-T therapies like Gilead Sciences’ Yescarta (axicabtagene ciloleucel) and Novartis’ Kymriah (tisagenlecleucel), which have lengthy and complex manufacturing and administration procedures and require in-hospital care.
