Benzinga | Dec 13, 2021 09:52AM EST

Janssen Secures Conditional EU Marketing Authorization For Rybrevant in Lung Cancer Setting

Johnson & Johnson's (NYSE:JNJ) Janssen subsidiary has received Conditional Marketing Authorization (CMA) approval from the European Commission for Rybrevant (amivantamab) for advanced non-small cell lung cancer (NSCLC).

* The approval comes for activating epidermal growth factor receptor (EGFR) exon 20 insertion mutations after the failure of platinum-based therapy.

* Amivantamab is the first approved treatment in the European Union specifically targeting EGFR exon 20 insertion mutations for NSCLC.

* The drug was approved by the FDA in May this year.

* The approval is based on results from the Phase I CHRYSALIS study.

* The investigator-assessed overall response rate was 37%, with a median duration of response of 12.5 months and 64% of patients having a duration of response greater than or equal to six months.

* Analysis showed that the median progression-free survival was 8.3 months, and the median overall survival in patients treated with amivantamab was 22.8 months.

* Price Action: JNJ shares are up 0.54% at $166.40 during the market session on the last check Monday.