The Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ) has filed an indication extension application with the US Food and Drug Administration (FDA) for its bispecific antibody Rybrevant (amivantamab) in combination with chemotherapy. The treatment is intended for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that harbor EGFR exon 19 deletions or L858R substitution, who have experienced disease progression on or after osimertinib (AstraZeneca’s (AZ, NASDAQ: AZN) Tagrisso). Rybrevant, a first-in-class anti-EGFR-MET biologic, currently holds an accelerated approval in the US for locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations after progression on or after chemotherapy.
Supporting Data from Phase III Trial
This week’s submission is backed by preliminary results from a Phase III trial, which evaluated key outcomes such as progression-free survival (PFS), objective response, overall survival (OS), and duration of response (DOR).
Ongoing Studies for Rybrevant in NSCLC
Rybrevant is also the subject of several additional studies for other NSCLC indications, expanding its potential impact on the treatment landscape for the disease.- Flcube.com
