Since its initial FDA approval in 2018 for the treatment of melanoma, encorafenib has continued to expand its indications, bringing new treatment options and hope to patients worldwide with a variety of diseases.
In 2018, it was approved for use in combination with other drugs for specific melanomas
On June 27, 2018, Array Biopharmaceuticals (later acquired by Pfizer) announced that the FDA had approved encorafenib in combination with mirtinocin tablets for the treatment of patients with unresectable or metastatic melanoma confirmed by FDA-approved testing methods to have BRAFV 600E or BRAFV 600K mutations. Braftol is not indicated for the treatment of wild-type BRAF melanoma.
In 2020, approval was granted for combination therapy in specific colorectal cancer cases
On April 8, 2020, Pfizer announced that the U.S. Food and Drug Administration (FDA) had approved encorafenib in combination with cetuximab (Erbitux) for the treatment of adult patients with metastatic colorectal cancer (CRC) confirmed by an FDA-approved test for the BRAFV 600E mutation and who have received prior therapy. This approval was based on results from the BEACONCRC trial, the only Phase 3 trial specifically targeting patients with previously treated BRAFV 600E-mutant metastatic colorectal cancer.
In 2023, approval was granted for combination therapy in specific non-small cell lung cancer cases
On October 12, 2023, Pfizer announced that the U.S. Food and Drug Administration (FDA) had approved encorafenib in combination with memetinib for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) confirmed by an FDA-approved assay to have the BRAFV 600E mutation. The BRAFV 600E mutation can be evaluated using either the FDA-approved companion diagnostic assay FoundationOneLiquidCDx (plasma-based) or FoundationOneCDx (tissue-based), respectively.
In 2024, approval was granted for combination therapy in specific colorectal cancer cases
On December 20, 2024, Pfizer announced that the U.S. Food and Drug Administration (FDA) had approved encorafenib in combination with cetuximab and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) for the treatment of patients with metastatic colorectal cancer (mCRC) harboring the BRAFV 600E mutation, detected by an FDA-approved test. This approval was based on statistically significant and clinically meaningful improvements in response rate and durability of response demonstrated by encorafenib in combination with cetuximab and mFOLFOX6 in treatment-naïve patients during the Phase 3 Breakwater trial. Continued approval for this indication is contingent on validation of clinical benefit.
