NEW YORK – China's National Medical Products Administration has approved AstraZeneca's osimertinib (Tagrisso) for the adjuvant treatment of EGFR-mutated, early-stage non-small cell lung cancer following surgery.
The NMPA approved the adjuvant indication for osimertinib based on the results of the Phase III ADAURA trial, in which the drug reduced the risk of disease recurrence or death by 83 percent among patients with stage II to IIIa NSCLC compared to placebo, and by 80 percent in the overall trial population with stage Ib to IIIa disease. The disease-free survival advantage on osimertinib was consistent among patients regardless of whether they received adjuvant chemotherapy, and whether they were Asian and non-Asian.
In the study, patients had to have tumors driven by EGFR exon 19 deletions or exon 21 (L858R) mutations. Researchers used Roche's cobas EGFR Mutation Test in a central lab to establish patients' EGFR mutation status. China carries a third of the world's lung cancer burden, and 40 percent of Chinese patients with NSCLC have EGFR-mutated tumors.
"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," Dave Fredrickson, executive VP of AstraZeneca's oncology business unit, said in a statement. "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."
This osimertinib indication, which received priority review from the NMPA's Center for Drug Evaluation, is the third approval for the drug in China, after second-line, EGFR T790M-driven NSCLC and first-line, EGFR-mutated NSCLC. Regulators in a more than a dozen countries, including in the US, have approved osimertinib in the adjuvant NSCLC setting based on the ADAURA data.