FDA approves Monjuvi for relapsed or refractory FL

The US Food and Drug Administration has approved US biotech Incyte’s (Nasdaq: INCY) Monjuvi (tafasitamab-cxix) with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma (FL).

The approval follows a Priority Review of the supplemental Biologics License Application (BLA), which was heavily informed by positive data from the Phase III inMIND trial.

The new authorization adds to Monjuvi's 2020 FDA green light in diffuse large B-cell lymphoma, although key opinion leaders view the drug primarily as salvage therapy. Analysts at Leerink have previously estimated worldwide peak sales for tafasitamab of ~$1 billion.