Posted from: Wednesday, May 16, 2018 - 04:43 PM - Present

New Indication for Tagrisso

April 18, 2018 – The U.S. FDA has approved a new indication for Tagrisso® (osimertinib), manufactured by AstraZeneca. The drug can now be used as a first-line treatment for metastatic non-small cell lung cancer (NSCLC) in patients whose tumors are positive, according to an FDA-approved diagnostic test, for epidermal growth factor receptor (EGFR) mutations.

In clinical trials, Tagrisso was shown to extend the length of progression-free survival (18.9 months) compared to the current standard of care (10.2 months), which consists of tyrosine kinase inhibitors (TKIs). Risk of disease progression and death fell 54% with Tagrisso versus TKIs.

AstraZeneca expects the drug to reach a $3 billion sales goal following the new indication. First approved in 2015, Tagrisso is also indicated to treat metastatic EGFR mutation positive NSCLC in patients whose disease has progressed during or after TKI therapy.

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Last Updated Friday, September 21, 2018 - 10:20 PM.