CHMP Recommends Approval Of Lazcluze + Rybrevant In EU For EGFR-mutated Advanced NSCLC

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(RTTNews) - Janssen-Cilag International NV, a Johnson & Johnson company (JNJ), Monday said that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Lazcluze in combination with Rybrevant for the first-line treatment of epidermal growth factor receptor (EGFR)-mutated advanced non-small cell lung cancer (NSCLC).

The CHMP has simultaneously recommended the approval of a Type II indication extension for amivantamab in the same combination treatment.

The CHMP positive opinions for the approval and the Type II extension of the indication are supported by data from the Phase III MARIPOSA study which evaluated Rybrevant in combination with Lazcluze compared with AstraZeneca's Tagrisso as first-line treatment of patients with EGFR-mutated NSCLC. The study had met its primary endpoint, reducing the risk of disease progression or death by 30 percent compared with Tagrisso. The median progression-free survival was 23.7 months versus 16.6 months for Tagrisso.