BRIEF—J&J submits to EMA for Rybrevant label expansion

Johnson & Johnson has submitted to broaden the label for Rybrevant (amivantamab) in Europe, to include combination use with lazertinib in the first-line treatment of non-small cell lung cancer (NSCLC).

First approved in South Korea in 2021, where it is marketed as Leclaza, lazertinib is an oral EGFR-TKI being developed by J&J in collaboration with Yuhan.

J&J wants to market the combo for people with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R (L858R) substitution mutations.

The submission is supported by data from the MARIPOSA study, which was featured as a late breaking abstract at the 2023 European Society of Medical Oncology (ESMO) Congress.

A marketing authorization application for lazertinib for the equivalent first-line combination was submitted to the EMA in December 2023.