Shots:

• AstraZeneca’s Tagrisso has received sNDA’s acceptance and has been granted PR in the US for the adjuvant treatment of patients with early-stage (IB- II- and IIIA) EGFRm NSCLC after complete tumor resection with curative intent
• The sNDA is based on the P-III ADAURA trial assessing Tagrisso (80mg- qd- PO) vs PBO for 3yrs. or until disease recurrence in the adjuvant treatment of 682 patients with stage IB- II- IIIA EGFRm NSCLC following complete tumour resection & adjuvant CT as indicated. Unprecedented results showed reduction in the risk of disease recurrence or death by 80% and improvement in DFS
• Tagrisso is an irreversible EGFR-TKI with clinical activity against CNS metastases with its expected PDUFA date in Q1’21

 ­ Ref: AstraZeneca | Image: Business Standard