Rybrevant (amivantamab) + chemotherapy is filed in Japan to treat NSCLC/EGFR
Janssen Pharmaceutical has made a Japan submission for its bispecific antibody amivantamab to be used in combination with chemotherapy for certain types of non-small cell lung cancer (NSCLC)
The Japan application for the drug, which carries the brand name Rybrevant in the US and Europe, seeks approval for the treatment of patients with inoperable or relapsed NSCLC with EGFR exon 20 insertion mutations.
The submission is based on the results of a global PIII trial dubbed the PAPILLON study, which evaluated the efficacy and safety of amivantamab plus chemotherapy in this population compared to chemotherapy alone. The combo therapy of amivantamab and chemotherapy showed a statistically significant and clinically meaningful improvement in progression-free survival, meeting the primary endpoint. The drug is a fully-human bispecific antibody that targets EGFR and MET receptors and works against tumors harboring activated or resistant EGFR and MET mutations or amplifications through immune competent cells.
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