It will be given as an adjuvant - which means it will be administered in addition to the initial treatment. And it will be used to target the early-stage epidermal growth factor receptor-mutated (EGFR) form of the disease “with curative intent”.
"For the first time, a targeted, biomarker-driven treatment option is available to patients in the US with early-stage EGFR-mutated lung cancer,” said Dave Fredrickson, vice president of AstraZeneca’s oncology business unit in a statement.
“This approval dispels the notion that treatment is over after surgery and chemotherapy, as the ADAURA phase III clinical trial results show that Tagrisso can dramatically change the course of this disease. We remain committed to treating cancer patients earlier, when they may still have a chance of being cured."
In a separate announcement, AstraZeneca also said the US Food and Drug Administration has requested “further clarifying analyses of clinical data” before considering whether to approve Roxadustat, a drug for people with anaemia from chronic kidney disease.