FDA approves Genentech Tecentriq combo for stage III colon cancer adjuvant

- FDA approval is based on results from the landmark Phase III ATOMIC study, published in The New England Journal of Medicine, which showed Tecentriq plus chemotherapy reduced the risk of disease recurrence or death by 50% compared to chemotherapy alone -- First approved adjuvant immunotherapy regimen for stage III dMMR colon cancer, positioning Tecentriq as a new post-surgery standard of care -- Nearly 25% of all colon cancers are diagnosed at stage III, and almost one in three patients with stage III colon cancer experience a recurrence within five years -- Approval marks the twelfth indication for Tecentriq in the U.S. SOUTH SAN FRANCISCO, Calif.--()--October 09, 2026-- Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Tecentriq(R) (atezolizumab) and Tecentriq Hybreza(R) (atezolizumab and hyaluronidase-tqjs) in combination with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of stage III deficient DNA mismatch repair (dMMR) colon cancer, a type of tumor characterized by high mutation rates. This approval marks the twelfth indication for Tecentriq in the U.S. "This approval provides a new adjuvant treatment option for people with stage III dMMR colon cancer who face a high risk of disease recurrence," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "Tecentriq combined with chemotherapy has the potential to become the new standard of care as the first approved immunotherapy-based regimen for this setting." "Until now, the adjuvant standard of care for stage III colon cancer has not differed based on mismatch repair status," said Frank A. Sinicrope, M.D., professor of oncology at the Mayo Clinic and U.S. principal investigator for the Alliance ATOMIC trial. "This milestone represents an important therapeutic advance that leverages immunotherapy to target the specific biology of dMMR stage III colon cancer after surgical resection. By reducing the risk of disease recurrence or death by 50%, atezolizumab plus chemotherapy is a practice-changing regimen that can improve clinical outcomes of this group of patients living with colon cancer, one of the most common cancers and a leading cause of cancer-related death." The FDA approval is based on the landmark Phase III ATOMIC study, recently published in The New England Journal of Medicine. ATOMIC demonstrated that adding Tecentriq to modified (m)FOLFOX6 chemotherapy reduced the risk of disease recurrence or death by 50%, compared to chemotherapy alone for people with stage III dMMR colon cancer, as determined by an immunohistochemistry test, such as the VENTANA(R) MMR RxDx Panel. The 36-month disease-free survival was 86% for Tecentriq combined with mFOLFOX6 compared with 76% in the mFOLFOX6 alone group. The safety profile was consistent with previous studies of Tecentriq and mFOLFOX6. Colon cancer remains one of the world's most common a

Adults with a type of bladder cancer called muscle invasive bladder cancer (MIBC) that has spread into the muscle layer of the bladder but not to other parts of the body. Tecentriq or Tecentriq Hybreza may be used alone as a treatment for your bladder cancer: -- to help prevent your bladder cancer from coming back after your bladder has been removed by surgery, and -- small pieces of DNA from the tumor (called circulating tumor DNA [ctDNA]) were found in your blood, showing that cancer cells remain in the body (molecular residual disease). Your healthcare provider will perform a test to make sure that Tecentriq or Tecentriq Hybreza is right for you. Adults and children with a type of colon cancer (Tecentriq is for children 2 years of age and older; Tecentriq Hybreza is for children 12 years of age and older and who weigh 88 pounds (40kg) or more). Tecentriq or Tecentriq Hybreza may be used with a fluoropyrimidine and oxaliplatin medicine: -- to help prevent your colon cancer from coming back after your tumor(s) have been removed by surgery, and -- you have stage 3 colon cancer, and your tumor has been shown by a laboratory test to be mismatch repair deficient (dMMR). It is not known if Tecentriq Hybreza is safe and effective when used: -- in children younger than 12 years of age for the treatment of ASPS or colon cancer. -- in children for the treatment of NSCLC, SCLC, HCC, melanoma or MIBC. It is not known if Tecentriq is safe and effective when used: -- in children younger than 2 years of age for the treatment of ASPS or colon cancer. -- in children for the treatment of NSCLC, SCLC, HCC, melanoma or MIBC. Important Safety Information Who should not receive Tecentriq Hybreza? Do not receive Tecentriq Hybreza if you are allergic to hyaluronidase or any of the ingredients in Tecentriq Hybreza. What is the most important information about Tecentriq and Tecentriq Hybreza? Tecentriq and Tecentriq Hybreza can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during your treatment or even after your treatment has ended. Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including: Lung problems -- cough -- shortness of breath -- chest pain Intestinal problems -- diarrhea (loose stools) or more frequent bowel movements than usual -- stools that are black, tarry, sticky, or have blood or mucus -- severe stomach-area (abdomen) pain or tenderness Liver problems -- yellowing of your skin or the whites of your eyes -- severe nausea or vomiting -- pain on the right side of your stomach area (abdomen) -- dark urine (tea colored) -- bleeding or bruising more easily than normal Hormone gland problems -- headaches that will not go

The FDA approved Tecentriq and Tecentriq Hybreza with a fluoropyrimidine and oxaliplatin for adjuvant treatment of Stage III dMMR colon cancer, based on Phase III ATOMIC data showing a 50% reduction in risk of recurrence or death vs chemo alone.Material DetailsContext by AI AnalystThis is a late-st…