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AstraZeneca's Tagrisso receives recommendation for approval in EU; Nirsevimab trial meets primary endpoint
StockMarketWire.com
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Pharma giant AstraZeneca said its lung cancer drug had been recommended for marketing authorisation in the European Union.
The Committee for Medicinal Products for Human Use of the European Medicines Agency based its positive opinion on results from the Adaura phase III trial evaluating Tagrisso to treat adult patients with early-stage epidermal growth factor receptor-mutated non-small cell lung cancer.
In the trial, Tagrisso demonstrated a 'statistically significant and clinically meaningful improvement in disease-free survival in the primary analysis population of patients with Stage II and IIIA early-stage epidermal growth factor receptor-mutated non-small cell lung cancer, and in the overall trial population of patients with Stage IB-IIIA disease,' the company said.
If approved, Tagrisso would be indicated for EGFRm patients whose tumours have exon 19 deletions or exon 21 (L858R) mutations.
In a separate statement, AstraZeneca said its Melody phase III trial of nirsevimab, used to treat RSV, met its primary goal.
RSV is a common, contagious virus that infects the respiratory tract causing millions of hospitalisations globally,
The primary endpoint of the trial was a 'statistically significant reduction in the incidence of medically attended lower respiratory tract infections (LRTI) caused by respiratory syncytial virus (RSV) compared to placebo in healthy late preterm and term infants (35 weeks or more) during their first RSV season,' the company said.
Story provided by StockMarketWire.com
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