ARTICLE | Top Story

FDA approves AZ's Tagrisso, companion diagnostic

November 14, 2015 1:56 AM UTC

FDA granted accelerated approval to Tagrisso osimertinib ( AZD9291) from AstraZeneca plc (LSE:AZN; NYSE:AZN) to treat T790M EGFR mutation-positive advanced non-small cell lung cancer (NCSLC) patients whose disease has worsened after EGFR-blocking therapy.

FDA also approved the cobas EGFR Mutation Test v2 companion diagnostic, an in vitro test that detects 42 mutations across the EGFR gene, including T790M. Roche (SIX:ROG; OTCQX:RHHBY) developed the diagnostic under a partnership with AZ (see BioCentury Extra, July 28, 2014). ...