AstraZeneca (AZ, NASDAQ: AZN), a leading UK pharmaceutical company, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued positive opinions for its drug Tagrisso (osimertinib). The EGFR-tyrosine kinase inhibitor (EGFR-TKI) is now recommended for approval to treat adult patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) that harbor specific EGFR mutations and have not experienced disease progression during or following platinum-based chemoradiation therapy (CRT).
CHMP Recommendation Details
The CHMP’s recommendation covers patients with tumours exhibiting epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations. This decision is grounded in the positive outcomes of the Phase III LAURA study, which demonstrated that Tagrisso significantly reduced the risk of disease progression or death by 84% compared to placebo. The median progression-free survival (PFS) for patients on Tagrisso was an impressive 39.1 months, contrasted with 5.6 months for those on placebo.
Global Regulatory Progress for Tagrisso
Tagrisso has recently gained approval in the US for use in adult patients with unresectable, Stage III EGFRm NSCLC following CRT. Additionally, regulatory submissions based on the LAURA trial data are currently under review in China, Japan, and several other countries, indicating the global significance and potential impact of Tagrisso in the treatment of NSCLC.-Fineline Info & Tech
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