FX.co ★ CHMP Recommends Approval Of Lazcluze + Rybrevant In EU For EGFR-mutated Advanced NSCLC

Janssen-Cilag International NV, a division of Johnson & Johnson (JNJ), announced on Monday that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Lazcluze when used in conjunction with Rybrevant. This approval is for the first-line treatment of advanced non-small cell lung cancer (NSCLC) with mutations in the epidermal growth factor receptor (EGFR).

In addition, the CHMP has recommended a Type II indication extension for amivantamab within the same combination therapy.

The positive opinions from the CHMP for both the approval and the Type II indication extension are based on evidence from the Phase III MARIPOSA trial. This research compared the combination of Rybrevant and Lazcluze to AstraZeneca's Tagrisso for first-line treatment in patients with EGFR-mutated NSCLC. The study achieved its primary objective, demonstrating a 30 percent reduction in the risk of disease progression or death compared to Tagrisso. The median progression-free survival observed was 23.7 months, as opposed to 16.6 months for those treated with Tagrisso.