Pierre Fabre Laboratories have received marketing authorisation in China for BRAFTOVI (encorafenib) in combination with cetuximab to treat adult patients with BRAFV600E-mutant metastatic colorectal cancer (mCRC) following prior systemic therapy.
The approval is based on results from the phase 3 BEACON CRC trial and the China-based NAUTICAL CRC bridging study.
Both studies showed significant survival benefits. BEACON CRC demonstrated a 40% reduction in risk of death, while NAUTICAL CRC showed a 45% reduction and a 63% decrease in disease progression or death among Chinese patients.
Marie-Andrée Gamache, CEO of Pierre Fabre Medical Care, said: “The marketing authorization for BRAFTOVI by the Chinese health authorities is a key milestone. Greater China is a priority strategic country for Pierre Fabre Laboratories.”
BRAF mutations occur in around 3–5% of Chinese mCRC patients, with V600E being the most common. These patients typically face poor outcomes and limited treatment options.
Núria Perez-Cullell, Head of Medical & Patient Consumer Department, said: “This approval represents a significant advancement and is crucial for the patients in China with BRAFV600E-mutant mCRC facing this particularly unfavorable prognosis cancer.”
Mr Tian Wee NG, Managing Director for Pierre Fabre Medical Care in Hong Kong and China, added: “The combination of BRAFTOVI with cetuximab provides renewed hope for Chinese metastatic colorectal cancer patients with a BRAFV600E mutation, offering a targeted cancer treatment regimen.”
The approval marks a major step in expanding precision oncology in China and reflects Pierre Fabre’s commitment to improving access to innovative therapies for hard-to-treat cancers.
