The Chinese regulatory approval is based on positive results from the Phase 3 ADAURA trial, which enrolled 682 patients in more than 20 countries
AstraZeneca Cambridge R&D Centre aerial view. (Credit: AstraZeneca.)
AstraZeneca has received China’s National Medical Products Administration (NMPA) approval for Tagrisso (osimertinib) to treat a type of non-small cell lung cancer (NSCLC).
NMPA indicated Tagrisso for patients with early-stage epidermal growth factor receptor-mutated (EGFRm) NSCLC, after tumour resection with curative intent.
Tagrisso is a third-generation, irreversible EGFR-TKI (tyrosine kinase inhibitor) with clinical activity against central nervous system metastases.
The drug has been approved to treat early-stage lung cancer in several countries, including the US, with additional global regulatory reviews are underway.
Also, it was approved for the treatment of metastatic EGFRm NSCLC, and metastatic EGFR T790M mutation-positive NSCLC in China, and the US, Japan, the EU and other countries.
AstraZeneca oncology business unit executive vice president Dave Fredrickson said: “The expedited approval of Tagrisso in China as part of a curative-intent regimen for early-stage EGFR-mutated lung cancer underscores the high unmet need in this setting and our commitment to improving outcomes in a country with one of the highest rates of EGFR mutations in the world.
“This approval reinforces the importance of EGFR testing across all stages of lung cancer, prior to treatment decisions, to ensure as many patients as possible can benefit from targeted therapies like Tagrisso and live cancer-free longer.”
NMPA approved Tagrisso based on positive results from the Phase 3 ADAURA trial, which enrolled 682 patients in over 200 centres across more than 20 nations.
In the Phase 3 trial, Tagrisso showed a statistically significant and clinically meaningful improvement in disease-free survival (DFS) in Stage II and IIIA patients, a primary endpoint.
The trial also showed a statistically significant and clinically meaningful improvement in DFS in patients with Stage IB-IIIA disease, a key secondary endpoint.
Adjuvant treatment with Tagrisso reduced the risk of disease recurrence or death by 83% in patients with Stage II and IIIA disease and by 80% in the overall trial population of patients with Stage IB-IIIA disease.
In the clinical trial, the safety and tolerability of Tagrisso were consistent with previous trials in the metastatic setting, said the company.