Encorafenib + cetuximab to treat mCRC

May 9, 2020 0 By FM

The US FDA has approved encorafenib (Braftovi) in combination with cetuximab for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAFV600E mutation, as detected by an FDA-approved test, after prior therapy. 

The approval is based on results from the BEACON CRC trial, the only phase 3 trial to specifically study patients with previously treated metastatic CRC with a BRAFV600E mutation.

Based on results from the BEACON CRC trial, encorafenib plus cetuximab showed a median overall survival (OS) of 8.4 months (95% CI: 7.5, 11.0) compared with 5.4 months (95% CI: 4.8, 6.6) for Control (irinotecan with cetuximab or FOLFIRI with cetuximab) ([HR 0.60, (95% CI: 0.45, 0.79), p=0.0003]).