AstraZeneca Reports the CHMP’s Positive Opinion of Tagrisso (Osimertinib) for Treating Unresectable EGFR-Mutated Lung Cancer
Shots:
- The CHMP has issued positive opinion for Tagrisso as a treatment of locally advanced, unresectable EGFRm (exon 19 deletions/exon 21 substitution) NSCLC (stage III) in patient, not progressed during or after Pt-based CRT. Regulatory findings are under review in China, Japan & other regions
- Opinion was based on P-III (LAURA) study assessing Tagrisso (80mg, QD, oral, until disease progression, unacceptable toxicity or other discontinuation criteria) vs PBO in the above-mentioned group of patients (n=216)
- Trial demonstrated 84% reduction in the risk of disease progression or death, as evaluated by BICR, with mPFS of 39.1 vs 5.6mos. and OS data was not mature, its evaluation is underway. Safety aligned with the previous studies. Data was published in the NEJM
Ref: AstraZeneca | Image: AstraZeneca
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
