EC approves added indication for Braftovi in mCRC

The European Commission (EC) has approved Braftovi (encorafenib) in combination with cetuximab (marketed as Erbitux by Eli Lilly [NYSE: LLY]) for the treatment of adult patients with BRAFV600E-mutant metastatic colorectal cancer (mCRC) who have received prior systemic therapy, says privately-held French drugmaker Pierre Fabre.

This approval is based on data from the Phase III BEACON CRC trial. The EC decision is applicable to all 27 EU member states plus Iceland, Liechtenstein, Norway and the UK. Braftovi posted $48 million in revenue in 2019.

“This approval is truly great news and much needed for patients with BRAFV600E-mutant mCRC and for physicians treating this devastating cancer, as until now, there has been no EC-approved therapies specifically indicated for this high-medical-need population,” said Dr Josep Tabernero, BEACON CRC trial lead investigator and director of the Vall d’Hebron Institute of Oncology in Barcelona, Spain. “The new encorafenib and cetuximab combination regimen will now change the way we treat these patients, with the possibility of delaying disease progression and prolonging their lives.”