FDA Requests Additional Study on AstraZeneca’s Imfinzi for Lung Cancer Treatment

1. FDA Requests Additional Study: The FDA has asked AstraZeneca to consider conducting another study on Imfinzi, its immune checkpoint drug, for use before and after lung cancer surgery, citing concerns over overtreatment in the current clinical trial.
2. Imfinzi's Performance in Bladder Cancer: Positive results from the NIAGARA Phase III trial showed that Imfinzi, in combination with chemotherapy, significantly improved event-free survival and overall survival in patients with muscle-invasive bladder cancer.
3. Imfinzi's Current Indications: Imfinzi is approved for various indications, including unresectable Stage III non-small cell lung cancer, extensive-stage small cell lung cancer, and metastatic non-small cell lung cancer, as well as other solid tumors.
4. AstraZeneca's Immuno-Oncology Program: AstraZeneca is actively developing Imfinzi across various cancer types, including early- and late-stage bladder cancer, in combination with other anti-cancer treatments.