Johnson & Johnson Gets FDA Approval for Advanced NSCLC with EGFR Mutations Treatment

The FDA has approved the use of Johnson & Johnson’s amivantamab in combination with carboplatin and pemetrexed for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) featuring EGFR exon 19 deletions or exon 21 L858R mutations.

The approval is based on the results from the phase 3 MARIPOSA-2 trial, which demonstrated improved progression-free survival (6.3 months) and overall response rates (53%) in patients treated with the combination compared to chemotherapy alone. The trial highlighted the potential of this regimen as an effective second-line therapy for patients after progression on EGFR-targeted treatments like osimertinib.

Amivantamab may address common resistance mechanisms and offers a new option for patients with high unmet needs in EGFR-mutated NSCLC. The combination therapy was generally well tolerated, with manageable side effects, including rash and fatigue, and offers potential to extend progression-free survival.

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