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September 29, 2021September 28, 2021 – The U.S. FDA has approved Eli Lilly's Erbitux® (cetuximab) for use with Pfizer's Braftovi® (encorafenib) to treat metastatic colorectal cancer (CRC) after prior therapy in adults who have a BRAF V600E mutation, as detected by an FDA-approved test.
- Erbitux is the first drug in its class (anti-EGFR antibodies) to be FDA approved for this indication.
- BRAF mutations occur in up to 15% of individuals who have metastatic CRC and are associated with a poor prognosis. BRAF V600E is the most common type of BRAF mutation and can significantly increase the risk of death.
- Recommended dosing under the new indication is as follows:
- Initial Dose: 400mg/m 2 of patient’s body surface area administered via two-hour intravenous (IV) infusion in combination with Braftovi.
- Subsequent Doses: 250mg/m 2 once weekly via one-hour IV infusion in combination with Braftovi until disease progression or unacceptable toxicity occur.
- Erbitux holds three additional indications to treat CRC, as well as three indications for the treatment of head and neck cancer.