The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for RYBREVANT (amivantamab-vmjw) plus chemotherapy (carboplatin-pemetrexed) for non-small cell lung cancer (NSCLC).
The sBLA is intended for the expanded approval of this combination therapy for the first-line treatment of patients with locally advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 20 insertion mutations.
The FDA is reviewing the application through the Real-Time Oncology Review (RTOR) programme.
Data from the Phase III PAPILLON clinical trial, an open-label and randomised study, supported the sBLA. The trial is assessing the safety and efficacy of the combination therapy for this specific indication.
Janssen Research & Development Solid Tumours Clinical Development vice-president Kiran Patel said: “PAPILLON is the first randomised Phase III study in patients with NSCLC with EGFR exon 20 insertion mutations to show clinically meaningful results.
“This creates an opportunity to make a significant improvement to the standard of care for this patient population with high unmet medical need.”
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In May 2021, the company secured accelerated approval from the FDA for RYBREVANT to treat adult patients with locally advanced or metastatic NSCLC.
Furthermore, the current sBLA submission for RYBREVANT also aims to fulfil the accelerated approval’s regulatory criteria, which validates the positive clinical outcomes seen in the Phase 1 CHRYSALIS study.