AstraZeneca: FDA grants priority review to Tagrisso
(CercleFinance.com) - US health regulators have granted priority review status for AstraZeneca's Tagrisso for the treatment of patients with early-stage EGFR-mutated lung cancer, the drugmaker said on Tuesday.
Tagrisso has received acceptance for its supplemental new drug application (sNDA) by the FDA, and has also been granted priority review for the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer, the company said.
Patients with early-stage EGFR-mutated lung cancer are considered to be at considerable risk of recurrence, even after surgery and chemotherapy.
Results showed treatment with Tagrisso reduced the risk of disease recurrence or death by 80% in a Phase III trial.
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