LONDON (dpa-AFX) - AstraZeneca PLC (AZN.L) Monday said European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended Tagrisso for approval to treat patients with unresectable epidermal growth factor receptor (EGFR)- muted non-small cell lung cancer (NSCLC) whose disease has not progressed during or following platinum-based chemoradiation therapy (CRT).
The positive opinion by the CHMP was based on results from the LAURA Phase 3 study, which showed Tagrisso reduced the risk of disease progression or death by 84 percent compared to placebo. Median progression-free survival was 39.1 months in patients treated with Tagrisso compared with 5.6 months for placebo.
Tagrisso following CRT was recently approved in the U.S. for the treatment of patients with unresectable, Stage III EGFRm NSCLC. Regulatory applications are under review in China, Japan and several other countries.
Tagrisso is already approved as monotherapy, in combination with chemotherapy, and both, in EGFR-muted NSCLC in many countries including U.S, E.U, China, and Japan.
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