Policy & Regulation
AstraZeneca granted Breakthrough Therapy Designation for Tagrisso in new indication
31 July 2020 -

AstraZeneca (LSE:AZN) (NYSE:AZN) (STO:AZN) has been awarded Breakthrough Therapy Designation (BTD) in the United States for Tagrisso (osimertinib), the biopharmaceutical company announced on Thursday.

This designation relates to the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumour resection with curative intent.

It comes after the Phase III ADAURA trial, in which Tagrisso reduced the risk of disease recurrence or death by around 80%.

BTD is granted by the US Food and Drug Administration to accelerate the development and regulatory review of potential new medicines that are intended to treat a serious condition and address a significant unmet medical need. Eligible medicines are expected to show encouraging early clinical results that demonstrate substantial improvement on a clinically significant endpoint over available medicines.

Tagrisso is already approved for the first-line treatment of patients with metastatic EGFRm NSCLC and for the treatment of metastatic EGFR T790M mutation-positive NSCLC in the US, Japan, China, the EU and other countries around the world.

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