The Food and Drug Administration (FDA) has approved Erbitux®
(cetuximab) in combination with Braftovi®
(encorafenib) for the treatment of adults with metastatic colorectal cancer with a BRAF
V600E mutation, as detected by an FDA-approved test, after prior therapy.
The approval is supported by data from the multicenter, open-label, phase 3 BEACON CRC trial (ClinicalTrials.gov Identifier: NCT02928224
) in adult patients with BRAF
V600E mutation-positive metastatic colorectal cancer with disease progression after 1 or 2 prior regimens. All patients received cetuximab 400mg/m2
intravenously for the first dose followed by 250mg/m2
weekly. Patients were randomly assigned 1:1:1 to receive: cetuximab plus encorafenib 300mg orally once daily (n=220), cetuximab plus binimetinib and encorafenib, or cetuximab with irinotecan or cetuximab with FOLFIRI (n=221; control arm).
Findings showed that cetuximab plus encorafenib demonstrated a statistically significant improvement in overall survival compared with the control arm (8.4 months [95% CI, 7.5-11.0] vs 5.4 months [95% CI, 4.8-6.6]; hazard ratio 0.60; 95% CI, 0.45-0.79; P
=.0003). Overall response rate was 20% (95% CI, 13-29) with cetuximab plus encorafenib compared with 2% (95% CI, 0-7) with the active comparator (P
<.0001). Median progression-free survival was 4.2 months (95% CI, 3.7-5.4) and 1.5 months (95% CI, 1.4-1.7) for the cetuximab plus encorafenib and control arms, respectively (hazard ratio 0.40; 95% CI, 0.31-0.52; P
“The BEACON study showed that the combination of Erbitux and encorafenib significantly improved overall survival in patients with metastatic colorectal cancer with a BRAF
V600E mutation – a subtype that typically has worse outcomes compared to those without the mutation,” said David Hyman, MD, chief medical officer, oncology at Lilly.
In April 2020
, the FDA approved Braftovi
for this indication based on data from the phase 3 BEACON CRC trial.
- FDA expands Lilly’s Erbitux® (cetuximab) label with combination of Braftovi® (encorafenib) for the treatment of BRAF V600E mutation-positive metastatic colorectal cancer (CRC) after prior therapy. News release. Eli Lilly and Company. Accessed September 29, 2021. https://www.prnewswire.com/news-releases/fda-expands-lillys-erbitux-cetuximab-label-with-combination-of-braftovi-encorafenib-for-the-treatment-of-braf-v600e-mutation-positive-metastatic-colorectal-cancer-crc-after-prior-therapy-301387268.html.
- Erbitux. Package insert. Eli Lilly and Company; 2021. Accessed September 29, 2021. http://pi.lilly.com/us/erbitux-uspi.pdf.
Source: Medical Bag https://www.medicalbag.com/home/news/erbitux-plus-encorafenib-approved-for-braf-v600e-mutation-positive-metastatic-colorectal-cancer/