This week the US Food and Drug Administration (FDA) approved Erbitux (cetuximab) in combination with platinum-based chemotherapy with 5-fluorouracil (CT), for the first-line treatment of recurrent locoregional or metastatic squamous cell carcinoma of the head and neck (SCCHN).
Head and neck cancers account for 3% to 5% of all cancers in the US, according to the National Cancer Institute. These cancers are more common in men and in people over the age of 50, and they typically develop in the nose, throat, or mouth.
“Erbitux’s ability to extend the lives of patients with head and neck cancers is an important tool for oncologists who often rely on a multi-treatment approach for patients,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research. “Given the aggressive nature of head and neck cancers that cannot be treated with surgery and radiation, it is important that patients have as many treatment options available as possible.”
The cetuximab plus CT treatment regimen, with extended overall survival in patients with recurrent locoregional or metastatic SCCHN, is the first of its kind approved in 30 years.
The approval is based on data from the EXTREME (ErbituX in first-line Treatment of REcurrent or MEtastatic head & neck cancer) trial, a multicenter clinical study conducted outside the United States involving 442 patients with metastatic or recurrent head and neck cancer. Study participants had not yet received prior chemotherapy and were diagnosed with inoperable or widespread disease. Researchers selected half to receive either the combination of cetuximab with chemotherapy or chemotherapy only. On average, patients receiving the cetuximab-chemotherapy combination treatment lived 10.1 months compared to 7.4 months for those patients receiving chemotherapy only.
“With the improvements seen across objective response rates, progression-free survival, and overall survival, this trial establishes ERBITUX plus CT as a important advancement in the treatment of first-line recurrent or metastatic SCCHN,” said Jan Vermorken, MD, PhD, Professor Emeritus at the University of Antwerp and primary investigator on the EXTREME trial. “[This] approval is important for patients with SCCHN because ERBITUX is the only biologic agent with a proven overall survival benefit in combination with CT in recurrent or metastatic disease.”
Source: FDA; Bristol-Myers Squibb.