FDA Grants Priority Review for Chemotherapy-Free Lymphoma Treatment

The FDA has granted priority review to a supplemental new drug application for zanubrutinib in combination with rituximab for adults with previously untreated mantle cell lymphoma. This potential regimen would be the first chemotherapy-free, BTK inhibitor-based treatment for this patient group, supported by Phase 3 trial data showing reduced disease progression or death risk. This development could offer a new, less toxic option for MCL patients.