China nod for Tagrisso on early-stage EGFR-mutated lung cancer

Marking another approval for the drug in the country, Anglo-Swedish pharma major AstraZeneca (LSE: AZN) has received approval in China for Tagrisso (osimertinib) for 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 tumor resection with curative intent, with or without adjuvant chemotherapy as recommended by the patient’s physician.

Tagrisso, which is AstraZeneca’s best-selling drug with 2020 sales of $4.33 billion, is indicated for EGFRm patients whose tumors have exon 19 deletions or exon 21 (L858R) mutations.

The approval by China’s National Medical Products Administration (NMPA) was based on positive results from the ADAURA Phase III trial. In the trial, Tagrisso demonstrated a statistically-significant and clinically meaningful improvement in disease-free survival (DFS) in the primary analysis population of patients with Stage II and IIIA EGFRm NSCLC. The ADAURA trial also showed a statistically-significant and clinically-meaningful improvement in DFS in the overall trial population of patients with Stage IB-IIIA disease, a key secondary endpoint.