Priority Review to Adjuvant Atezolizumab Plus Chemotherapy for Stage III dMMR Colon Cancer

 The FDA has accepted and granted priority review to the supplemental biologics license application (sBLA) for atezolizumab (Tecentriq) and atezolizumab/hyaluronidase-tqjs (Tecentriq Hybreza, Roche) in combination with chemotherapy as adjuvant treatment for patients with stage III mismatch repair–deficient (dMMR) or microsatellite instability–high (MSI-H) colon cancer following surgical resection.1

A target action date of October 9, 2026, has been set by the FDA for the application under the Prescription Drug User Fee Act (PDUFA). If approved, the combination would represent the first immunotherapy-based adjuvant regimen available for this molecularly defined patient population.

https://www.onclive.com/view/fda-grants-priority-review-to-atezolizumab-adjuvant-regimen-for-stage-iii-dmmr-c