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Evidence, not a headline
New Colorectal Cancer Treatments in 2026
In 2026, China added defined options for biomarker groups, not a new treatment for every colorectal cancer. Reported NMPA wording approves trastuzumab rezetecan for adults with HER2-positive disease after oxaliplatin, fluorouracil, and irinotecan have failed. A 2026 CSCO interpretation moves a BRAF V600E combination into first-line care. The NMPA label verified here for encorafenib remains the cetuximab doublet after prior systemic therapy. Trial permission for a PD-L1 and 4-1BB antibody is not an approval to treat.
Applicability: approved, guideline-supported, clinical trial, and IND are different statuses. They are not collapsed in the table.
APPROVEDGUIDELINE-SUPPORTEDIND is not a label
2026 evidence matrix
| Approach | Biomarker / population | Line / setting | China status | Evidence | What it does not prove | Updated |
|---|---|---|---|---|---|---|
| Trastuzumab rezetecan (SHR-A1811), a HER2 antibody-drug conjugate | HER2-positive colorectal cancer in adults | After oxaliplatin, fluorouracil, and irinotecan have failed | APPROVED | Company and news reports in August 2026 of an NMPA new indication. The phase 3 HORIZON-CRC01 report at ASCO 2026 described median IRC progression-free survival of 5.5 versus 2.8 months (HR 0.33) at a median follow-up of 9.6 months. | Not a treatment for HER2-low disease, not a first-line approval, and not a result for unselected colorectal cancer. A response rate is not a cure. | 3 October 2026 |
| Encorafenib plus cetuximab | BRAF V600E metastatic colorectal cancer | After prior systemic therapy | APPROVED | NMPA marketing authorization reported in July 2025, supported by BEACON CRC and the China NAUTICAL CRC study. This is company and regulatory reporting. | Not proof that the first-line triplet has the same China label. Not a treatment for BRAF-wild-type disease. | 3 October 2026 |
| Encorafenib plus an anti-EGFR antibody, with FOLFOX in selected patients | RAS wild-type, BRAF V600E, and MSS, MSI-L, or pMMR | Moved into first-line metastatic care in the 2026 interpretation | GUIDELINE-SUPPORTED | Cao and Jiang, published 1 October 2026, say a BRAF V600E targeted combination was moved into first-line metastatic care. Chinese summaries of the 2026 CSCO update name FOLFOX plus encorafenib plus an anti-EGFR antibody as a grade I option for fit RAS-wild-type, MSS or pMMR patients, and the doublet for patients who are not fit for intensive therapy. Those grades are from the summaries, not from a pasted guideline. BREAKWATER, in the New England Journal of Medicine in 2025, studied encorafenib, cetuximab, and mFOLFOX6 before treatment for metastatic disease. | Not the July 2025 NMPA label. That label, as reported, is the post-therapy doublet. A secondary summary is not the guideline PDF, and a journal article is not hospital stock. | 3 October 2026 |
| Checkpoint immunotherapy, including nivolumab alone or with ipilimumab in the CSCO interpretation | The established setting is MSI-H or dMMR disease | Metastatic first-line in that interpretation | GUIDELINE-SUPPORTED | Cao and Jiang, published 1 October 2026, say nivolumab alone or with ipilimumab was added as a first-line grade I recommendation in metastatic disease. That sentence does not itself write MSI-H. This page does not read it as covering MSS or pMMR cancer. | Not established routine care for MSS or pMMR colorectal cancer. Not a product recommendation for every PD-1 antibody sold in China. | 3 October 2026 |
| FOLFOX plus atezolizumab | Stage III dMMR colon cancer after surgery | Adjuvant, in the 2026 CSCO interpretation | GUIDELINE-SUPPORTED | Cao and Jiang, published 1 October 2026, say FOLFOX plus atezolizumab was added as an adjuvant option for stage III dMMR disease. The same article separates upfront surgery from neoadjuvant immunotherapy in non-metastatic MSI-H or dMMR colon cancer. | Not an NMPA approval claim on this page. Not a treatment for MSS or pMMR stage III cancer. Not a reason to skip surgery. | 3 October 2026 |
| Opamtistomig (LBL-024), a PD-L1/4-1BB bispecific antibody | Metastatic colorectal cancer; biomarkers were described as exploratory | Investigational combination | IND | Leads Biolabs announced on 2 August 2026 that China’s CDE had approved an IND for a phase Ib/II combination trial. That announcement is company reporting. | IND approval is not treatment approval. The August 2026 NDA accepted for this antibody is for extrapulmonary neuroendocrine carcinoma, not colorectal cancer. No colorectal efficacy result is claimed here. | 3 October 2026 |
Status words are kept separate on purpose. APPROVED means a reported regulator authorization for a defined population. GUIDELINE-SUPPORTED means a 2026 CSCO interpretation, which is not the same document as an NMPA label. IND means permission to study a drug. EARLY RESEARCH is not used in this table because no extra preclinical row was needed.
HER2-positive disease
The reported NMPA wording is adults with HER2-positive colorectal cancer after failure of oxaliplatin, fluorouracil, and irinotecan. Fluorouracil is the drug named in those reports. This page does not widen that to every fluoropyrimidine, to HER2-low tumors, or to people who have not received those three drugs. A company mention of a first-line combination with a high response rate is a different, earlier study and is not this approval. The phase 3 comparison was against a later-line standard in a biomarker-selected population. Median progression-free survival of 5.5 months is not a cure.
BRAF V600E
BRAF V600E marks a higher-risk metastatic colorectal cancer. The NMPA authorization this page relies on is encorafenib plus cetuximab after prior systemic therapy, reported in July 2025. Cao and Jiang say a BRAF V600E targeted combination was moved into first-line care in the 2026 CSCO guideline. Chinese summaries of that update name FOLFOX plus encorafenib plus an anti-EGFR antibody as a grade I option for fit RAS-wild-type, MSS or pMMR patients, and the doublet when intensive therapy is not suitable. Those grades are labelled here as secondary summaries. They are not written as a second NMPA label. BREAKWATER supports the scientific case for the triplet. A trial publication is not hospital stock.
What was not added as a new approval
No new anti-EGFR antibody was verified as a 2026 China approval for this page, so that row was left out. Proton therapy, ablation, and cryoablation were not relabelled as 2026 colorectal drugs. The current NHC specification is the 2025 edition. It organizes surgery, drug therapy, radiation, imaging, and pathology. It is not this 2026 drug table.
China access
Whether a labelled drug is reachable for an international patient is a different page: colorectal cancer treatment in China. The map of decisions is colorectal cancer treatment.
In this cluster
- Colorectal cancer treatment
- Treatment by stage
- Metastatic disease
- Immunotherapy
- New treatments in 2026 (this page)
- Treatment in China
Technology pages already on this site, used only when a case actually needs them: proton therapy, microwave ablation, cryoablation, and interventional oncology. None of those replaces surgery or systemic therapy for colorectal cancer as a default.
Questions people ask
What new colorectal cancer treatments were introduced in China in 2026?
The verified 2026 addition is trastuzumab rezetecan for adults with HER2-positive colorectal cancer after oxaliplatin, fluorouracil, and irinotecan have failed. CSCO 2026 interpretations also move encorafenib-based combinations earlier for selected BRAF V600E disease. An IND for a PD-L1/4-1BB antibody is trial permission, not a new approved treatment.
Can HER2-positive colorectal cancer be targeted?
Yes, in a defined later-line population. Reported NMPA wording covers adults with HER2-positive colorectal cancer after failure of oxaliplatin, fluorouracil, and irinotecan. It does not cover every HER2 test result, and it does not cover untreated disease.
What does BRAF V600E mean in colorectal cancer?
It is a mutation found in a minority of colorectal cancers and it marks higher-risk metastatic disease. Encorafenib plus cetuximab is the post-therapy combination reported as authorized in China. First-line use with chemotherapy is a guideline and trial question, not the same label.
Sources
- NCI, Colon Cancer Treatment (PDQ) patient version. Used for the general distinction between colon treatment and a personal plan.
- NCI, Rectal Cancer Treatment (PDQ) patient version. Used for the point that rectal cancer more often involves radiation than colon cancer.
- National Health Commission colorectal cancer specification, 2025 edition. English summary: Chin J Cancer Res 2025;37(6):949-961. doi 10.21147/j.issn.1000-9604.2025.06.07. This is a practice framework, not a 2026 drug list.
- CSCO colorectal guideline version 2026, as interpreted in Chin J Cancer Res 2026;38(3):329-335. doi 10.21147/j.issn.1000-9604.2026.03.10. The full guideline PDF was not pasted here.
- Cao and Jiang, 1 October 2026. Digestive Oncology, electronic edition, 2026;18(3):358-363. Used for the metastatic nivolumab sentence, the stage III dMMR adjuvant sentence, and the first-line BRAF move.
- Guangming, 10 August 2026, reporting NMPA wording for adults with HER2-positive colorectal cancer after failure of oxaliplatin, fluorouracil, and irinotecan. HORIZON-CRC01 was reported at ASCO 2026. This is company and news reporting, not an opened NMPA gazette page.
- CancerNetwork, 13 July 2025, reporting NMPA authorization of encorafenib plus cetuximab for adults with previously treated BRAF V600E metastatic colorectal cancer, from a Pierre Fabre release. BREAKWATER: Elez and colleagues, N Engl J Med 2025;392:2425-37. doi 10.1056/NEJMoa2501912.
- BioPharm International, 3 August 2026, reporting the Leads Biolabs announcement that CDE approved an IND for a phase Ib/II trial of opamtistomig plus other drugs in metastatic colorectal cancer. A separate August 2026 NDA acceptance for the same antibody is for extrapulmonary neuroendocrine carcinoma, not colorectal cancer.
Last reviewed: 3 October 2026. A trial permission, a guideline sentence, and a drug label are three different documents.
Separate a 2026 approval from a headline
A new drug label applies only to a defined marker and line of therapy. ParkMega does not enroll trials or promise that a hospital in China stocks the drug.