- The European Union on Wednesday granted conditional approval to AstraZeneca's lung cancer drug Tagrisso, making it the first new drug approved under the European Commissions' expedited process.
- Tagrisso is indicated for the treatment of a type of non-small cell lung cancers (NSCLC) with a mutation known as T790M that makes tumors more resistant to medication.
- This EU approval comes only two months after the US FDA okayed the drug in November 2015.
AstraZeneca has high hopes for Tagrisso. It has forecast sales as high as $3 billion a year, making the drug an important contributor to the company's goal of increasing revenue to $45 billion by 2023.
The EU used an accelerated process to approve Tagrisso. As part of the conditional approval, treatment eligibility will be determined by a diagnostic test to check for the T790M mutation.
The FDA also approved Tagrisso through an accelerated process after designating it for both priority review and as an orphan drug. Only two and a half years passed between the commencement of clinical trials and final approval.
Two Phase 2 studies demonstrated an objective response rate as measured by tumor shrinkage of 66% along with a median progression-free survival of 9.7 months.