FDA expands approval of Imfinzi in non-small cell lung cancer

The US Food and Drug Administration (FDA) has expanded its approval of Imfinzi (durvalumab) to now include the treatment of patients with stage III non-small cell lung cancer (NSCLC) whose tumours are unresectable and have not progressed after chemoradiation treatment.

“This is the first treatment approved for stage III unresectable non-small cell lung cancer to reduce the risk of the cancer progressing, when the cancer has not worsened after chemoradiation,” stated Dr Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “For patients with stage III lung cancer that cannot be removed surgically, the current approach to prevent progression is chemoradiation. Although a small number of patients may be cured with the chemoradiation, the cancer may eventually progress. Patients now have an approved therapy that has been shown to keep the cancer from progressing for a longer time after chemoradiation.”

“The approval of Imfinzi in this earlier stage of non-small cell lung cancer is a truly meaningful milestone for patients who, until now, had no FDA-approved treatment options following chemoradiation therapy,” said Dave Fredrickson, executive vice president, head of the Oncology Business Unit at AstraZeneca. “Globally, approximately 30% of patients with NSCLC present with Stage III disease and we are excited to launch the first immunotherapy into this setting.”

“Until now, treatment guidelines have recommended that patients with unresectable Stage III lung cancer undergo a period of active surveillance following chemoradiation therapy until disease progression. Given that up to 89% of patients will progress to metastatic disease, it is important that there is now a new option that can give patients more time without disease progression,” commented Dr Scott J. Antonia, PhD, chair of the Thoracic Oncology Department at the H. Lee Moffitt Cancer Center and Research Institute in Tampa and investigator in the PACIFIC trial. “The PACIFIC trial data supporting today’s approval of Imfinzi will change how we treat these patients.”

This extended approval was based on the positive progression-free survival data from the PACIFIC trial, where Imfinzi demonstrated an improvement compared with placebo. The trial is ongoing and will evaluate the overall survival rate in unresectable stage III NSCLC.