FDA green light for first targeted therapy for subset of NSCLC

On Friday, the US Food and Drug Administration approved Rybrevant (amivantamab-vmjw) as the first treatment for adult patients with non-small cell lung cancer (NSCLC) whose tumors have specific types of genetic mutations: epidermal growth factor receptor (EGFR) exon 20 insertion mutations.

Granted to Johnson & Johnson (NYSE: JNJ) subsidiary Janssen, the approval is an important development for people living with NSCLC with exon 20 insertion mutations who, until now, have had no approved treatment options to target their disease. Rybrevant is the first FDA-approved targeted therapy for patients with these mutations, which are the third most prevalent acting EGFR mutations.

This milestone also marks Janssen’s first approval for the treatment of patients with lung cancer and reflects the progress it has made to develop and deliver transformational therapies to people diagnosed with some of the most complex diseases.