FDA Grants Approval to Blood-based Companion Diagnostic for Tagrisso

The FDA approved a companion diagnostic test for Tagrisso (osimertinib), which uses a tissue or blood sample to confirm T790M mutations in patients with metastatic non-small cell lung cancer. The diagnostic, the cobas EGFR Mutation Test v2, was developed by Roche Molecular Systems.

Blood-based testing for the presence of the mutation is recommended only when a tumor biopsy cannot be obtained. Physicians who receive a negative result for the epidermal growth factor receptor T790M mutation with the blood-based test should re-evaluate the feasibility of tissue-based testing to confirm the presence of the mutation, according to AstraZeneca, Tagrisso’s sponsor.

Tagrisso received accelerated approval in November 2015 as a targeted medicine for the treatment of EGFR T790M mutation-positive NSCLC, which has progressed on or after an EGFR tyrosine kinase inhibitor medicine.