Incyte (NASDAQ:INCY) announced Wednesday that the U.S. Food and Drug Administration (FDA) approved a label expansion for its immunotherapy product Monjuvi as part of a combination regimen for adults with follicular lymphoma, a cancer affecting white blood cells.
The decision marks the second U.S.-approved indication for Monjuvi, which Incyte (NASDAQ:INCY) markets under licensing agreements with Xencor (NASDAQ:XNCR) and MorphoSys (OTCPK:MPSYF).
Specifically, the anti-CD19 monoclonal antibody will be available in the U.S. for adults with relapsed or refractory follicular lymphoma in combination with rituximab, a cancer therapy, and lenalidomide, a multiple myeloma therapy marketed by J&J (JNJ) as Revlimid.
The FDA has approved Incyte’s (NASDAQ:INCY) supplemental Biologics License Application for Monjuvi under its priority review program based on the company’s Phase 3 inMIND trial, which met its primary endpoint, indicating a statistically significant improvement in progression-free survival (PFS).
In 2020, the FDA greenlighted the treatment in combination with lenalidomide for adults with diffuse large B-cell lymphoma under the agency’s accelerated approval pathway.
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