FDA Approves AstraZeneca’s Cancer Drug Tagrisso

The FDA Nov. 13 granted accelerated approval to Tagrisso (osimertinib) for treating patients with advanced non-small cell lung cancer (NSCLC).

Tagrisso is approved for patients whose tumors have a specific epidermal growth factor receptor (EGFR) gene mutation (T790M) and whose disease worsened after treatment with other EGFR-blocking therapy, the Food and Drug Administration said. The EGFR gene is a protein involved in the growth and spread of cancer cells.

The FDA also said it approved the first companion diagnostic test (cobas EGFR Mutation Test v2) to detect the type of EGFR resistance mutation that Tagrisso is known to target. The ...