The FDA granted accelerated approval to dostarlimab for adults with stage II or III locally advanced rectal cancer whose tumors are MSI-H or dMMR, based on data from an international trial in which 71% of patients received the drug alone without progression requiring additional treatment. The decision adds to the growing role of mismatch repair status in rectal cancer treatment selection. In parallel, AbbVie reported a Phase 3 win for lutikizumab, its IL-1α/IL-1β inhibitor, in a painful skin condition with an FDA filing expected next year—an indicator of continued late-stage progress for anti-inflammatory biologics beyond classic inflammatory pathways. Together, the two updates underscore how biomarker definition and targeted immunology remain central to current FDA decision-making. For companies, the combination of rapid regulatory movement in oncology and disciplined follow-on filing timelines in immunology may influence how they structure late-stage programs and biomarker strategies, particularly around measurable response endpoints.