The United States (US) Food and Drug Administration (FDA) granted accelerated approval on October 19, 2026, to dostarlimab (Jemperli, GSK) for adults with Stage II/III locally advanced rectal cancer (LARC) that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), as determined by an FDA-authorized test for solid tumors. The decision was supported by data […]
On October 8, 2026, the U.S. Food and Drug Administration (FDA) approved adjuvant atezolizumab (Tecentriq, Genentech, Inc.) in combination with a fluoropyrimidine and oxaliplatin among patients two years of age and older with completely resected Stage III mismatch repair deficient (dMMR) colon cancer. The FDA simultaneously approved the subcutaneous (SC) formulation, atezolizumab and hyaluronidase-tqjs (Tecentriq […]
AbbVie announced on October 7, 2026, that the U.S. Food and Drug Administration has granted two Breakthrough Therapy Designations for telisotuzumab adizutecan (Temab-A; ABBV-400), an investigational c-Met-directed antibody-drug conjugate. The designations cover two separate indications: Temab-A in combination with bevacizumab for refractory, metastatic colorectal cancer, and Temab-A as a monotherapy for locally advanced or metastatic […]
The U.S. Food and Drug Administration (FDA) has accepted supplemental Biologics License Applications (sBLAs) and granted Priority Review to atezolizumab (Tecentriq) and atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza), each in combination with chemotherapy, for the adjuvant treatment of stage III deficient mismatch repair (dMMR) or microsatellite instability-high (MSI-H) colon cancer. The applications are supported by results […]
A phase I first-in-human study of telisotuzumab adizutecan (Temab-A, ABBV-400) — a novel c-Met–targeting antibody-drug conjugate (ADC) — has reported encouraging efficacy and a manageable safety profile in heavily pretreated patients with metastatic colorectal cancer (mCRC). Published in the Journal of Clinical Oncology, these findings position Temab-A as a potential future option in the third-line […]
Postsurgical ctDNA-defined MRD status predicts which patients with resected colorectal liver metastases benefit from adjuvant chemotherapy, according to the CIRCULATE-Japan GALAXY study. The findings support personalized, biomarker-driven treatment decisions after surgery.
Constipation may be a more important warning sign of early-onset colorectal cancer than previously recognized, according to a large national inpatient analysis. The association was strongest in women younger than 40, underscoring the need for greater clinical vigilance and earlier evaluation of persistent symptoms.
The phase III BREAKWATER trial evaluated early integration of targeted therapy with encorafenib plus cetuximab in combination with chemotherapy for patients with previously untreated BRAF V600E–mutated metastatic colorectal cancer (mCRC). Results demonstrated significantly improved response rates and progression-free survival (PFS) compared with standard chemotherapy, supporting FDA traditional approval of this targeted combination in the frontline […]