ODAC Votes No on IntraDose Injectable Cisplatin/Epinephrine Gel for Head and Neck Cancer

In 2001, the Oncologic Drugs Advisory Committee unanimously voted against recommending approval for IntraDose, an injectable cisplatin/epinephrine gel, for treating recurrent or refractory squamous cell carcinoma of the head and neck. Despite some clinical response, the trials showed a low overall response rate of 20-30% and minimal clinical and patient benefit. The FDA criticized the trials for issues such as symptom improvement not correlating with objective response rates, frequent dosing errors, and safety concerns, including strokes and other adverse events. The committee concluded that the potential benefits did not outweigh the toxicity risks, leading to the decision not to approve the drug.