---
title: 'Regulatory Daily Summary: What Happened on October 9, 2026'
headline: FDA adds Tecentriq to postsurgical treatment for stage III dMMR colon cancer
description: The agency also approved nine new molecular entities in September, bringing
  its year-to-date total to 45.
url: https://thebench.bio/news/regulatory/2026-10-09
topic: regulatory
date: '2026-10-09'
covers:
- '2026-10-09'
date_published: '2026-10-09T12:02:32Z'
date_modified: '2026-10-09T12:02:32Z'
sources: 2
publisher: The Bench (thebench.bio)
---

# Regulatory Daily Summary: What Happened on October 9, 2026

**FDA adds Tecentriq to postsurgical treatment for stage III dMMR colon cancer**

The agency also approved nine new molecular entities in September, bringing its year-to-date total to 45.

## Today in brief

Roche’s Tecentriq, or its subcutaneous version Tecentriq Hybreza, can now be used with chemotherapy after surgery for certain patients with stage III dMMR colon cancer, following FDA approval. [1] In the Phase III ATOMIC trial, Tecentriq plus modified FOLFOX6 cut the risk of recurrence or death by half compared with chemotherapy alone. [1]

CDER approved nine new molecular entities in September, taking its 2026 total to 45. [2]

## Tecentriq gains a postsurgical role in stage III dMMR colon cancer

The FDA approved Roche’s Tecentriq, or the subcutaneous formulation Tecentriq Hybreza, with fluoropyrimidine and oxaliplatin for postsurgical treatment of certain patients with stage III mismatch repair-deficient (dMMR) colon cancer. [1] The approval makes this the first immunotherapy-based option authorized for this patient group and treatment setting. [1]

The decision followed Phase III ATOMIC results, in which Tecentriq plus modified FOLFOX6 reduced the risk of recurrence or death by 50% compared with chemotherapy alone. [1] Roche is pursuing additional European regulatory filings for Tecentriq in dMMR colon cancer. [1]

## The day in numbers

- **50%**: Reduction in recurrence or death risk with Tecentriq plus modified FOLFOX6 versus chemotherapy alone in the ATOMIC trial. [1]
- **45**: New molecular entities approved by the FDA’s Center for Drug Evaluation and Research so far in 2026. [2]

## Also published

- [MHRA Chair Professor Anthony Harnden: Bringing our strategy to life – listening, learning, and looking ahead](<https://www.gov.uk/government/news/mhra-chair-professor-anthony-harnden-bringing-our-strategy-to-life-listening-learning-and-looking-ahead>), MHRA

## Sources

1. [Roche’s Tecentriq snags FDA label expansion in type of colon cancer ](<https://www.pharmaceutical-technology.com/news/roche-tecentriq-fda-label-expansion-dmmr-colon-cancer-stage-iii/>), Pharmaceutical Technology, 2026-10-09
2. [FDA’s CDER approved nine NMEs in September](<https://www.biocentury.com/article/661093/fda-s-cder-approved-nine-nmes-in-september?utm_source=bc_rss&utm_medium=rss>), BioCentury, 2026-10-09

---

The Bench wrote this from the reporting cited above, with a language model drafting and editing.

[1]: <https://www.pharmaceutical-technology.com/news/roche-tecentriq-fda-label-expansion-dmmr-colon-cancer-stage-iii/>
[2]: <https://www.biocentury.com/article/661093/fda-s-cder-approved-nine-nmes-in-september?utm_source=bc_rss&utm_medium=rss>