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FDA Approves Encorafenib in Combination with Cetuximab for mCRC with a BRAF V600E Mutation

Evidence for efficacy is based on the results from the BEACON CRC trial
15 Apr 2020
Targeted Therapy
Colon and Rectal Cancer

On 8 April 2020, the US Food and Drug Administration (FDA) approved encorafenib (BRAFTOVI, Array BioPharma Inc.) in combination with cetuximab for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, detected by an FDA-approved test, after prior therapy.

Efficacy was evaluated in a randomised, active-controlled, open-label, multicentre trial (BEACON CRC; NCT02928224). Eligible patients were required to have BRAF V600E mutation-positive metastatic CRC (detected by the Qiagen therascreen® BRAF V600E RGQ PCR kit) with disease progression after one or two prior regimens.

A total of 220 patients were randomised to encorafenib (300 mg orally once daily) in combination with cetuximab and 221 patients were randomised to the control arm of either irinotecan or FOLFIRI with cetuximab.

The major efficacy outcome measure was overall survival (OS). Additional efficacy outcome measures included progression-free survival (PFS), overall confirmed response rate (ORR), and duration of response (DoR). The ORR and DoR were assessed by blinded independent central review in the subset of the first 220 patients randomised to receive either encorafenib plus cetuximab or the control arm.

Median OS was 8.4 months (95% confidence interval [CI] 7.5, 11.0) in the encorafenib and cetuximab arm compared to 5.4 months (95% CI 4.8, 6.6) in the control arm (hazard ratio [HR] 0.60; 95% CI 0.45, 0.79; p = 0.0003).

Median PFS was 4.2 months (95% CI 3.7, 5.4) in the encorafenib and cetuximab arm compared to 1.5 months (95% CI 1.4, 1.7) in the control arm (HR 0.40; 95% CI 0.31, 0.52; p < 0.0001).

The ORR was 20% (95% CI 13%, 29%) and 2% (95% CI 0%, 7%), respectively.

Median DoR was 6.1 months (95% CI 4.1, 8.3) for the encorafenib and cetuximab arm and not reached (95% CI 2.6, NR) in the control arm.

The most common adverse reactions (≥25%) for encorafenib with cetuximab were fatigue, nausea, diarrhoea, dermatitis acneiform, abdominal pain, decreased appetite, arthralgia, and rash.

The recommended encorafenib dose is 300 mg orally once daily in combination with cetuximab.

Full prescribing information for BRAFTOVI is available here.

This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. This application was granted priority review and breakthrough therapy designation.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System.

For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact FDA’s Oncology Center of Excellence Project Facilitate.

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