Article Content

The FDA has removed the clinical hold that had been imposed on the phase III cancer study with leukocyte interleukin injection. All clinical trial activities under this Investigational New Drug application may resume.

FDA; head  neck canc... - Click to enlarge in new windowFDA; head & neck cancer. FDA; head & neck cancer

Leukocyte interleukin injection is being studied as a potential first-line immunotherapy. The study has enrolled 928 newly-diagnosed head and neck cancer patients, and all the patients who have completed treatment continue to be followed for protocol-specific outcomes in accordance with the study protocol.


The study's primary endpoint is a 10 percent increase in overall survival for patients treated with the treatment regimen plus standard of care (SOC) versus those who receive SOC only. The determination if the study's primary endpoint has been met will occur when there are a total of 298 deaths in those two groups. Current SOC for this indication is surgery, followed by radiation therapy alone or concurrent radio-chemotherapy.


There is a clear and unmet medical need for a new treatment in this indication as the last FDA-approved treatment for advanced primary head and neck cancer was over 50 years ago. The FDA has also designated this treatment an Orphan Drug for neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck.