Sign in Subscribe

approved

A collection of 13 issues

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

Adding Chemotherapy to Immunotherapy May Extend Survival in MSI-H Metastatic CRC

Skip to content The CRC Digest ◆ TRIAL DATA Adding Chemotherapy to Immunotherapy May Extend Survival in MSI-H Metastatic CRC The phase III NRG-GI004/SWOG S1610 COMMIT trial found that combining mFOLFOX6, bevacizumab, and atezolizumab may prolong progression-free survival over atezolizumab alone in first-line treatment of mismatch repair–deficient/microsatellite instability–

FDA Approves SimpleScreen CRC Blood Test for Average-Risk Adults

Skip to content The CRC Digest ● REGULATORY FDA Approves SimpleScreen CRC Blood Test for Average-Risk Adults The FDA has approved SimpleScreen CRC, a new blood-based screening option for colorectal cancer in adults aged 45 and older at average risk, based on data from the PREEMPT CRC trial. (The ASCO Post)

FDA approves second blood test to help close colorectal cancer screening gap

Skip to content The CRC Digest ● REGULATORY FDA approves second blood test to help close colorectal cancer screening gap The FDA has approved a second blood-based screening test for colorectal cancer, expanding options for patients who may avoid traditional colonoscopy. (AOL.com) This content is informational only and does not