Encorafenib and Cetuximab Combination Receives Approval in China for BRAF V600E+ Metastatic CRC

On July 11, 2025, the Chinese National Medical Products Administration (NMPA) granted marketing authorization for the combination of encorafenib (Braftovi) and cetuximab (Erbitux) as a treatment for adults with previously treated metastatic colorectal cancer (mCRC) harboring BRAF V600E mutations. This significant approval is based on robust data from the phase 3 BEACON CRC trial and the phase 2 NAUTICAL CRC trial, which provided critical insights into the efficacy of this treatment regimen.

The BEACON CRC trial, which has been a cornerstone of this approval, demonstrated that the combination therapy achieved a median overall survival (OS) of 8.4 months compared to 5.4 months for the control group receiving standard treatments. This outcome was supported by a substantial reduction in the risk of death, with a hazard ratio (HR) of 0.60 (95% CI, 0.45-0.79; P < .001) for the encorafenib/cetuximab arm. The objective response rate (ORR) was significantly higher in the experimental arm at 20% compared to just 2% in the control arm (P < .001).

The approval has been heralded as a groundbreaking advancement for patients in China suffering from BRAF V600E-mutant mCRC, a population previously lacking specific treatment options. According to Núria Perez-Cullell, head of the Medical & Patient Consumer Department at Pierre Fabre Laboratories, "This approval represents a significant advancement and is crucial for the patients in China with BRAF V600E-mutant metastatic CRC with this particularly unfavorable prognosis cancer. Until now, no treatment specifically intended for this population has been approved by the Chinese authorities, leaving an unmet medical need.”

The NAUTICAL CRC trial, also pivotal in supporting the approval, reinforced these findings, reporting a median progression-free survival (PFS) of 4.2 months for the combination therapy versus 2.5 months for the control (stratified HR, 0.37; P = .0004). Additionally, the median OS was reported as 11.6 months for the encorafenib/cetuximab arm compared to 8.2 months in the control group.

Both trials indicated that while adverse effects were common, they were manageable, with the most frequently reported grade 3 or higher toxicities being anemia and vomiting. The potential for this combination therapy to change the clinical landscape for BRAF V600E-mutant mCRC in China cannot be overstated, as it introduces a new therapeutic avenue aimed at improving patient outcomes significantly.

The FDA had previously approved this combination in April 2020 based on the findings from the BEACON CRC trial, which has now paved the way for its acceptance in other global markets, including China. This move reflects a growing recognition of the urgent need for effective therapies in this challenging cancer population both domestically and internationally.

As healthcare providers and patients await further clinical guidance, the approval of encorafenib and cetuximab is expected to alter treatment paradigms, offering hope where options were previously limited. Experts anticipate that this could lead to more comprehensive treatment strategies and improved overall life expectancy for patients diagnosed with this aggressive form of colorectal cancer.