AstraZeneca last week announced the approval by the U.S. Food and Drug Administration of IMFINZI. The drug treats Stage III non-small cell lung cancer.
“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 and 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.”
The approval is based on data from the Phase III PACIFIC trial.
“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,” said Scott J. Antonia, M.D., Ph.D., chair of the Thoracic Oncology Department at the H. Lee Moffitt Cancer Center and Research Institute in Tampa, Florida. “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.”