UK-based AstraZeneca (AZ, NASDAQ: AZN) has announced that it has received a new indication approval from China’s National Medical Products Administration (NMPA) for its non-small cell lung cancer (NSCLC) treatment, Tagrisso (osimertinib). This approval is for the use of Tagrisso in treating adult patients with locally advanced, unresectable NSCLC, whose tumors exhibit epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations, and who have not experienced disease progression during or following platinum-based chemoradiation therapy (CRT).
Phase III LAURA Study Results Support NMPA’s Decision
The NMPA’s endorsement is supported by the positive results from the Phase III LAURA study, which demonstrated that Tagrisso significantly reduced the risk of disease progression or death by 84% compared to placebo (hazard ratio 0.16; 95% confidence interval 0.10-0.24; p<0.001). The median progression-free survival (PFS) for patients treated with Tagrisso was 39.1 months, a substantial improvement over the 5.6 months observed in the placebo group.
Central Nervous System Progression and Distant Metastasis Reduction
Tagrisso also reduced the risk of central nervous system (CNS) progression or death by 83% (p<0.001) and showed a clinically significant improvement in median time to distant metastasis (TTDM) (p<0.001). At 12 months, the cumulative incidence of TTDM in the Tagrisso treatment group was 11%, compared to 37% in the placebo group. The clinical benefits observed in Chinese patients are consistent with those of global patients, with PFS rates of the 12-month and 24-month treatment groups receiving Tagrisso at 80% and 71%, respectively, while the placebo group was only at 17% and 8%.
Global Approvals for Tagrisso
Tagrisso, a third-generation, irreversible EGFR-TKI, has received approvals in multiple regions worldwide for various EGFR mutant NSCLC indications, further solidifying its position as a leading treatment option in the fight against NSCLC.-Fineline Info & Tech
