By Fineline Cube 
Merck KGaA (ETR: MRK) announced that the Chinese National Medical Products Administration (NMPA) has granted marketing approval for a new indication of Erbitux (Cetuximab Injection). The approval authorizes the drug in combination with Braftovi (Encorafenib) for adult patients with BRAF V600E mutation‑positive metastatic colorectal cancer (mCRC) who have previously received systemic therapy. This marks the fifth indication for Erbitux in China.
Clinical Evidence Supporting the Approval
| Study | Design | Population | Key Findings |
|---|---|---|---|
| BEACON CRC | Randomized, multicenter, Phase III | Global mCRC patients | Combination of Erbitux + Braftovi increased overall survival vs. standard therapy; 40 % risk‑reduction in death |
| NAUTICAL | Bridging study in China | Chinese mCRC patients | 45 % reduction in risk of death with Erbitux + Braftovi vs. control |
- Survival Benefit – The global BEACON study demonstrated a statistically significant overall survival advantage, while the NAUTICAL study confirmed comparable efficacy in the Chinese population.
- Safety Profile – Incidence of adverse events was consistent with the known safety profile of Erbitux and Braftovi, supporting the combination’s tolerability.
Strategic Impact for Merck KGaA
- Expanded Portfolio – The new indication strengthens Merck KGaA’s position in the oncology market, adding a valuable treatment option for a high‑risk patient subgroup.
- Market Penetration – With China’s largest oncology patient base, the approval unlocks significant commercial potential.
- Pipeline Synergy – The partnership between Erbitux and Braftovi aligns with Merck KGaA’s focus on targeted therapies for oncogenic mutations.
Forward‑Looking Statements
This release contains forward‑looking statements that involve risks and uncertainties. Actual results may differ materially.-Fineline Info & Tech