Tagrisso osimertinib regulatory update

FDA granted accelerated approval of AstraZeneca’s Tagrisso osimertinib to treat EGFR T790M mutation-positive, metastatic non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, in patients who have progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy. The oral irreversible inhibitor of EGFR-activating mutations and the T790M EGFR resistance mutation has breakthrough therapy status and was under Priority Review (see BioCentury, April 28, 2014).

FDA concurrently approved a PMA from Roche (SIX:ROG; OTCQX:RHHBY, Basel, Switzerland) for the cobas EGFR Mutation Test v2 as a companion diagnostic for Tagrisso. Roche and AZ co-developed the in vitro diagnostic test that detects 42 mutations across the EGFR gene, including T790M, under a 2014 deal (see BioCentury Aug. 4, 2014). ...