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FDA Approves Encorafenib–Cetuximab Combo for BRAF V600E-Mutated mCRC
On April 8, 2020, the FDA approved encorafenib (Braftovi; Array BioPharma) in combination with cetuximab for the treatment of adults with pretreated metastatic colorectal cancer (CRC) and a BRAF V600E mutation, detected by an FDA-approved test.
This approval was based on data from the BEACON trial. A total of 441 patients with BRAF V600E mutation–positive metastatic CRC that progressed after 1 of 2 regimens were enrolled in this study.
The main efficacy end point was overall survival. Additional outcomes observed were progression-free survival, overall response rate, and duration of response.
Investigators behind the trial randomized patients to receive encorafenib 300 mg once daily in combination with cetuximab (n = 220) or irinotecan or FOLFIRI plus cetuximab (control arm; n = 221).
The encorafenib plus cetuximab arm had a median overall survival of 8.4 months versus 5.4 months in the control arm; the median progression-free survival was 4.2 months and 1.5 months, respectively. In the encorafenib plus cetuximab arm, the overall response rate was 20% versus 2% in the control arm, and the median duration of response was 6.1 months versus not reached, respectively.
Fatigue, nausea, diarrhea, dermatitis acneiform, abdominal pain, decreased appetite, arthralgia, and rash were the most common (≥25%) adverse reactions.—Kaitlyn Manasterski
Source: USA Food and Drug Administration. FDA approves encorafenib in combination with cetuximab for metastatic colorectal cancer with a BRAF V600E mutation. Updated April 9, 2020. www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-encorafenib-combination-cetuximab-metastatic-colorectal-cancer-braf-v600e-mutation. Accessed April 9, 2020
