The U.S. Food and Drug Administration approved AstraZeneca’s Imfinzi (durvalumab) for the treatment of patients with stage III non-small cell lung cancer whose tumors are not able to be surgically removed and whose cancer has not progressed after treatment with chemotherapy and radiation.
The OK came after a late-stage study showed the drug increased survival rates by nearly a year.
“This is the first treatment approved for stage III unresectable non-small cell lung cancer to reduce the risk of cancer progressing, when the cancer has not worsened after chemoradiation,” said Richard Pazdur, M.D., 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 cancer from progressing for a longer time after chemoradiation.”
Lung cancer is the leading cause of cancer death in the United States, with an estimated 222,500 new diagnoses and 155,870 deaths in 2017, according to the National Cancer Institute at the National Institutes of Health. The most common type of lung cancer, NSCLC occurs when cancer cells form in the tissues of the lung. Stage III NSCLC means tumors have spread to nearby lymph nodes or into other parts of the body near the lungs.
Imfinzi targets proteins found on the body’s immune cells and some cancer cells. By blocking these interactions, Imfinzi may help the body’s immune system attack cancer cells. Imfinzi was previously granted accelerated approval in 2017 for the treatment of certain patients with locally advanced or metastatic bladder cancer.
The median progression-free survival for patients taking Imfinzi was 16.8 months compared to 5.6 months for patients receiving a placebo. In addition, AZ has agreed to a post-marketing commitment to provide additional information from their study to the FDA about how long patients lived following treatment with Imfinzi after chemotherapy and radiation (overall survival).
Common side effects of Imfinzi in patients with stage III unresectable NSCLC include cough, fatigue, inflammation in the lungs (pneumonitis/radiation pneumonitis), upper respiratory tract infections, difficulty breathing (dyspnea) and rash.
Serious risks of Imfinzi include immune-mediated side effects, where the body’s immune system attacks healthy cells or organs.
The FDA granted this application Priority Review and Breakthrough Therapy designations.
Stock in AZ rose in after-hours trading. Endpoints reported the drug is a potentially big win for the company, which has struggled with disappointing outcomes to its R&D efforts.
The British-Swedish company has been working to deal patent cliff that came as blockbuster drugs lost protection from generics. AstraZeneca revenues have dropped from $33 billion in 2011 to less than $23 billion in 2017.
AstraZeneca, at last report, employed about 1,500 in Delaware after corporate cuts that included the loss of research and development facilities in the state.
