J&J beats Tagrisso and Takeda to the punch in key NSCLC subset, picking up new FDA approval

Looking to outflank AstraZeneca’s best-selling drug in a non-small cell lung cancer niche, J&J scored an important approval Friday afternoon.

Regulators gave the thumbs-up to Janssen’s amivantamab for the treatment of metastatic NSCLC with EGFR exon 20 insertion mutations, the FDA announced Friday. It’s the first drug approved to treat such patients, with J&J planting a stake in a part of the EGFR mutation arena where its competitors have struggled to gain a foothold.