FDA Approves Erbitux Plus Braftovi for Pretreated Colorectal Cancer Subtype

The FDA has approved Braftovi plus Erbitux for pretreated patients with BRAF V600E-mutant metastatic colorectal cancer.

The Food and Drug Administration (FDA) approved a new indication for Erbitux (cetuximab) plus Braftovi (encorafenib) for pretreated BRAF V600E-mutant metastatic colorectal cancer (CRC), according to Lilly, the manufacturer of Erbitux.

The approval is based on findings from the phase 3 BEACON CRC trial, which demonstrated that the drug combination led to an average overall survival (time that a patient with cancer is still alive after starting treatment) rate of 8.4 months compared with 5.4 months in patients in the control group who received irinotecan with Erbitux or FOLFIRI (a chemotherapy combination to treat metastatic colorectal cancer) with Erbitux. A total of 20% of patients who received Erbitux and Braftovi responded to treatment, while only 2% did in the control group.

Average progression-free survival — defined as time patients lived without their disease getting worse — was 4.2 months and 1.5 months in the combination and control groups, respectively.

"The BEACON study showed that the combination of Erbitux and (Braftovi) 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 Dr. David Hyman, chief medical officer of oncology at Lilly, in a statement.

The most common side effects that occurred in 25% or more of patients receiving Erbitux and Braftovi were fatigue, nausea, diarrhea, dermatitis acneiform (skin rash), abdominal pain, decreased appetite, joint pain and rash. The labeling for Erbitux warns patients and clinicians about infusion reactions, cardiac arrest, pulmonary toxicity, skin toxicity, hypomagnesemia and other electrolyte abnormalities, and embryo-fetal toxicity.

The approval is welcomed in the space, as about 149,000 people will be diagnosed with cancer in the colon or rectum this year, with an estimated 15% harboring a BRAF mutation — most commonly BRAF V600E.

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