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Press Release

September 29, 2021
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FDA approves Erbitux with Braftovi for colorectal cancer subset

Source:

Press Release

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The FDA approved cetuximab in combination with encorafenib for treatment of certain patients with colorectal cancer.

The indication applies to use of the agents by adults with BRAF V600E mutation-positive metastatic disease detected by an FDA-approved test who received prior therapy.

Approved FDA_Shutterstock
Source: Shutterstock.

Cetuximab (Erbitux, Eli Lilly) is an epidermal growth factor receptor inhibitor. Encorafenib (Braftovi, Pfizer) is an oral small molecule kinase inhibitor that targets BRAF V600E.

The FDA based the approval on results of the randomized phase 3 BEACON CRC trial, which included patients with BRAF V600E-mutant metastatic colorectal cancer that progressed after one or two prior regimens.

Researchers randomly assigned patients to one of three regimens: encorafenib 300 mg orally once daily in combination with cetuximab; encorafenib 300 mg orally once daily in combination with cetuximab and binimetinib (Mektovi, Array Pharmaceuticals); or cetuximab with either irinotecan or FOLFIRI.

OS served as the major efficacy outcome. Additional efficacy outcomes included PFS, objective response rate and duration of response.

As Healio previously reported, results showed longer median OS (8.4 months vs. 5.4 months; HR = 0.6; 95% CI, 0.45-0.79), longer median PFS (4.2 months vs. 1.5 months; HR = 0.4; 95% CI, 0.31-0.52) and a higher ORR (20% vs. 2%; P < .0001) among patients assigned the cetuximab-encorafenib combination than those assigned cetuximab plus either irinotecan or FOLFIRI.

The most common adverse events reported among patients who received the cetuximab-encorafenib combination included fatigue, nausea, diarrhea, dermatitis acneiform, abdominal pain, decreased appetite, arthralgia and rash.

"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 [with] those without the mutation," David Hyman, MD, chief medical officer for oncology at Lilly, said in a company-issued press release. “We are grateful to Pfizer for their collaboration as we've worked to bring this treatment regimen to patients.”

The FDA approved encorafenib for this indication in April 2020 based on data from the BEACON CRC trial.