Health · Pharma & Biotech · 2 days ago
FDA approves atezolizumab with chemotherapy for some stage III colon cancers
The FDA approved atezolizumab, an immunotherapy drug, with chemotherapy after surgery for people with stage III colon cancer whose tumors have deficient DNA mismatch repair.
This DNA repair defect is called dMMR.
The treatment is intended to reduce the chance that cancer returns after surgery.
Until now, standard follow-up treatment for stage III colon cancer has been chemotherapy with a fluoropyrimidine and oxaliplatin.
In a trial involving 712 people in the United States and Germany, adding atezolizumab reduced the risk of recurrence or death by 50% compared with chemotherapy alone.
After three years, 86.3% of those given the combination were disease-free, compared with 76.2% of those who received chemotherapy alone.
The approval makes the combination an option for this specific group of patients.
The U.S. Food and Drug Administration approved atezolizumab (Tecentriq) with fluoropyrimidine and oxaliplatin chemotherapy as adjuvant treatment for patients with stage III colon cancer with deficient mismatch repair (dMMR).
The approval was based on the phase III Alliance ATOMIC trial, sponsored by the National Cancer Institute and conducted with Genentech and Germany’s Arbeitsgemeinschaft Internistische Onkologie.
The trial enrolled 712 participants in the United States and Germany between September 2017 and January 2023.
Adding atezolizumab reduced the risk of recurrence or death by 50%, according to the trial findings reported in the article.
At three years, 86.3% of patients who received atezolizumab with chemotherapy remained disease-free, compared with 76.2% of those who received chemotherapy alone.
- Who
- The FDA; patients with stage III dMMR colon cancer
- What
- Approval of atezolizumab with fluoropyrimidine and oxaliplatin chemotherapy as adjuvant treatment
- When
- Thursday, October 8, 2026, according to MedPage Today
- Where
- United States; the trial enrolled participants in the United States and Germany
- Why
- The ATOMIC trial found improved disease-free survival when atezolizumab was added to standard chemotherapy
This story does not have two clearly opposing sides.
The FDA approval of atezolizumab for patients with stage III dMMR colon cancer is a significant milestone for patients and for the Alliance.
The ATOMIC results show what is possible when investigators across the country come together around a common goal.
The ATOMIC trial began enrolling participants.
The trial's enrollment period ended after 712 participants had joined in the United States and Germany.
The FDA approved atezolizumab with chemotherapy for adjuvant treatment of stage III dMMR colon cancer, according to MedPage Today.
News-Medical reported the FDA approval and the ATOMIC trial results.
- Trial
- Alliance ATOMIC (A021502), a phase III trial
- Participants
- 712, enrolled in the United States and Germany
- Disease-free at three years
- 86.3% with atezolizumab plus chemotherapy; 76.2% with chemotherapy alone
- Recurrence or death risk
- Reduced by 50% with atezolizumab added to chemotherapy, as reported in the article
- Trial sponsor
- National Cancer Institute
Sources
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