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news.The US Food and Drug Administration (FDA) has approved ImClone's cetuximab (Erbitux) in combination with platinum-based therapy plus 5-florouracil (5-FU) to treat recurrent locoregional disease and/or metastatic squamous cell carcinoma of the head and neck (SCCHN).
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A multi-center clinical study, whic involved 442 patients and used European Union (EU) approved cetuximab, led to the approval.
In the trial, 222 patients received cetuximab plus cisplatin (or carboplatin) with 5FU and 220 patients received cisplatin (or carboplatin) with 5-FU.
Either cisplatin (100 mg/m2 intravenously day 1) or carboplatin (AUC 5 intravenously day 1) with 5-FU (1000 mg/m2/day continuous intravenous infusion days 1-4) were administered every 3 weeks (1 cycle).
Cetuximab, 400 mg/m2 intravenously, was administered as an initial dose followed by cetuximab, 250 mg/m2 intravenously weekly, in combination with chemotherapy.
The major efficacy outcome measure of the trial was overall survival (OS). Other outcome measures included progression-free survival (PFS) and objective response rate (ORR).
Patients receiving cetuximab plus chemotherapy showed improvement in progression-free survival.
The approved dose of Erbitux is 400 mg/m2 intravenously as an initial dose, followed by 250 mg/m2 intravenously weekly in combination with cisplatin or carboplatin plus continuous infusion 5-FU.