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A collection of 16 issues

FDA converts pembrolizumab approval for TMB-high tumors, raises threshold to ≥13 mutations/megabase

Skip to content The CRC Digest ● REGULATORY FDA converts pembrolizumab approval for TMB-high tumors, raises threshold to ≥13 mutations/megabase The FDA granted traditional approval for pembrolizumab in unresectable or metastatic TMB-high solid tumors, updating the definition from ≥10 to ≥13 mutations/megabase after efficacy was not confirmed in the

FDA approves dostarlimab for MSI-H/dMMR locally advanced rectal cancer

Skip to content The CRC Digest ● REGULATORY FDA approves dostarlimab for MSI-H/dMMR locally advanced rectal cancer The accelerated approval covers stage II or III rectal cancer and is based on the AZUR-1 trial. At median follow-up of 26.3 months, 110 of 154 patients (71%) had received dostarlimab alone,

FDA grants accelerated approval to dostarlimab for MSI-H/dMMR locally advanced rectal cancer

Skip to content The CRC Digest ● REGULATORY FDA grants accelerated approval to dostarlimab for MSI-H/dMMR locally advanced rectal cancer On October 19, 2026, the FDA granted accelerated approval to dostarlimab for adults with Stage II/III locally advanced rectal cancer that is MSI-H or dMMR. The approval was based

FDA grants breakthrough device designation to Natera's multi-cancer blood test

Skip to content The CRC Digest ▪ SCREENING FDA grants breakthrough device designation to Natera's multi-cancer blood test The investigational assay analyzes cell-free DNA to screen for multiple cancer types, including colorectal cancer, from a single blood sample; no MCED test has yet received FDA approval. (Targeted Oncology) This

ATOMIC trial shows 86% three-year disease-free survival with atezolizumab combination

Skip to content The CRC Digest ◆ TRIAL DATA ATOMIC trial shows 86% three-year disease-free survival with atezolizumab combination At a median follow-up of 40.9 months in the ATOMIC trial, the 3-year disease-free survival rate was 86.3% in patients receiving atezolizumab plus mFOLFOX6 compared with 76.2% in those

FDA approves atezolizumab plus chemotherapy for Stage III dMMR colon cancer

Skip to content The CRC Digest ● REGULATORY FDA approves atezolizumab plus chemotherapy for Stage III dMMR colon cancer The FDA approved atezolizumab in combination with a fluoropyrimidine and oxaliplatin for adjuvant treatment of adult and pediatric patients two years and older with Stage III mismatch repair deficient colon cancer. Efficacy

Abbott launches SimpleScreen CRC blood test for average-risk adults 45+

Skip to content The CRC Digest ▪ SCREENING Abbott launches SimpleScreen CRC blood test for average-risk adults 45+ The FDA-approved blood-based screening test, developed by Freenome and sold exclusively by Abbott, is designed for adults unwilling or unable to undergo colonoscopy. (Fierce Biotech) This content is informational only and does not

Fruquintinib approved in U.S., EU, and China for previously treated metastatic CRC

Skip to content The CRC Digest ▸ TREATMENT Fruquintinib approved in U.S., EU, and China for previously treated metastatic CRC This oral VEGF receptor inhibitor demonstrated consistent efficacy in two Phase 3 trials: FRESCO (enrolling patients in China) and FRESCO-2 (enrolling patients across 14 countries in North America, Europe, Asia,

FDA delays decision on zanzalintinib plus Tecentriq for metastatic colorectal cancer until March 2027

Skip to content The CRC Digest ● REGULATORY FDA delays decision on zanzalintinib plus Tecentriq for metastatic colorectal cancer until March 2027 The FDA has extended its approval decision for Exelixis' oral kinase inhibitor zanzalintinib in combination with Roche's Tecentriq to March 2027 while awaiting updated safety and

Blood-Based Screening Now Available Starting at Age 45

Skip to content The CRC Digest Blood-Based Screening Now Available Starting at Age 45 The newly FDA-approved SimpleScreen CRC blood test is available for adults aged 45 years and older who are at average risk for colorectal cancer. (The ASCO Post) This content is informational only and does not constitute