FDA expands Tecentriq use in a defined colon cancer group

The FDA approved Tecentriq (atezolizumab), with chemotherapy, as post-surgery (adjuvant) treatment for stage III colon cancer with deficient mismatch repair (dMMR). The approval also covers Tecentriq Hybreza, an under-the-skin formulation, for eligible patients.

The decision was based on the phase III ATOMIC study:
adding Tecentriq to modified FOLFOX6 chemotherapy reduced the risk of recurrence or death by 50% versus chemotherapy alone. The approval applies to a specific biomarker-defined group, not colon cancer generally.

The UK medicines regulator revoked Ixchiq’s marketing authorization after a benefit–risk review focused on its use by travelers. Valneva said the decision relied on already-known safety information, not a new adverse safety finding.

The UK withdrawal does not affect Ixchiq authorizations in the EU, Canada, Brazil, or other markets. Valneva said it had not actively distributed the vaccine in the UK for several months and expects little financial impact.