Pierre Fabre gets China nod for cancer drug

Braftovi combination to treat patients with Brafv600e-mutant metastatic colorectal cancer 

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Pierre Fabre gets China nod for cancer drug

Pierre Fabre Laboratories, the world’s second-largest dermo-cosmetics company, has announced that the Chinese authorities granted the marketing authorization for Braftovi, in combination with cetuximab, for the treatment of adult patients with Brafv600e-mutant metastatic colorectal cancer, after prior systemic therapy. 

The approval in China is based on the Phase 3 Beacon CRC trial, the pivotal study that led to the approval in EU and US, that demonstrated a significant improvement in overall survival of patients treated with Braftovi in combination with cetuximab, as well as on the bridging study NAUTICAL CRC conducted in China which demonstrated similar results in Chinese patients. 

According to the Beacon CRC trial, the data showed that Braftovi in combination with cetuximab significantly improved overall survival in patients with Brafv600e-mutant mCRC and the risk of death was reduced by 40% in Beacon CRC and 45% in Nautical CRC. 

Nautical CRC achieved its primary objective, demonstrating an estimated 63.0% reduction in the risk of disease progression or death among Chinese subjects receiving Braftovi in combination with cetuximab compared to the control group.

“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. We are proud to bring this therapeutic option to Chinese patients fighting Brafv600e-mutant mCRC, and our teams are poised to make the launch a success in partnership with Chinese authorities and health care professionals.” added Marie-Andrée Gamache, CEO of Pierre Fabre Medical Care.

BRAF mutations are estimated to occur in approximately 3-5% of Chinese patients with mCRC, with V600E being the most common mutation. Patients with mCRC who have Brafv600e-mutant tumours generally have a poor prognosis representing a high unmet medical need. 

“This approval represents a significant advancement and is crucial for the patients in China with Brafv600e-mutant mCRC facing 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. From now, encorafenib in combination with cetuximab will change the approach to treating the patients in China, offering the possibility to slow disease progression and improve their life expectancy,” said Núria Perez-Cullell, head of Medical & Patient Consumer Department.

“The approval of Braftovi in China underscores our unwavering commitment to advancing care for patients facing challenging-to-treat cancers and delivering precision medicine,” stated Tian Wee NG, managing director, Pierre Fabre Medical Care, Hong Kong/China. 

“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. This approval highlights our dedication to addressing significant unmet medical needs within the oncology landscape and reinforces our mission to deliver innovative and accessible treatment options. By integrating cutting-edge science with patient-centered care, we aim to significantly enhance the quality of life for Chinese patients and contribute to the fight against cancer.”

Braftovi is an oral small molecule kinase inhibitor that targets Brafv600e. Inappropriate activation of proteins in the MAPK signaling pathway (RAS-RAF-MEK-ERK) has been shown to occur in certain cancers, including CRC.

Pfizer has exclusive rights to Braftovi in the US, Canada, Latin America, Middle East, and Africa. Ono Pharmaceutical has exclusive rights to commercialize the product in Japan and South Korea, Medison has exclusive rights to commercialize the product in Israel and Pierre Fabre Laboratories has exclusive rights to commercialize the product in all other countries, including Europe and Asia (excluding Japan and South Korea).

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