The EMA has approved a new drug for the benefit of patients with non-small cell lung cancer (NSCLC). It is amivantamab (Janssen), a new drug for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion activating mutations, following the failure of platinum-based therapy. Amivantamab is the first treatment approved in the European Union specifically targeting EGFR exon 20 insertional mutations in NSCLC.
This group of patients today presented few treatment options, so the approval of this new molecule is a major milestone. The marketing authorization for amivantamab is based on the results of the Phase 1 CHRYSALIS study, a multicenter, open-label clinical trial evaluating amivantamab as monotherapy in patients after prior treatment with platinum-based therapy, which has demonstrated efficacy and an overall well-tolerated safety profile. The investigator-assessed overall response rate was 37% (95% CI, 28%-46%), with a median duration of response of 12.5 months (95% CI, 6.5-16.1) and duration of response greater than or equal to 6 months in 64% of patients. The analysis showed that the median progression-free survival (time elapsed without progression or death) was 8.3 months (95% CI, 6.5-10.9) and the median overall survival in patients treated with amivantamab was 22.8 months (95% CI, 14.6-not reached).
This approval supports the approval already given by the US Food and Drug Administration (FDA), which approved it in May 2021.
