FDA OK's expanded use of AstraZeneca’s Tagrisso in lung cancer

 

• Under the Real-Time Oncology Review pilot program, the FDA approves AstraZeneca’s (AZN -1.9%) Tagrisso (osimertinib) for the adjuvant treatment of adult patients with early-stage epidermal growth factor receptor-mutated ((EGFRm)) non-small cell lung cancer (NSCLC) after tumor resection with curative intent.
• Tagrisso was approved in the U.S. for EGFR T790M mutation-positive NSCLC in November 2015 and first-line EGFR-positive NSCLC in April 2018.
• In China, Tagrisso is under priority review for the adjuvant treatment of patients with early-stage EGFRm NSCLC. This indication is also under regulatory review in the EU and additional global submission discussions are ongoing.
• https://seekingalpha.com/news/3646182-fda-oks-expanded-use-of-astrazeneca-s-tagrisso-in-lung-cancer