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  • Conversation: FDA approves Janssen’s Rybrevant

    • May 24, 2021 1:21 PM BST
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      FDA approves Janssen’s Rybrevant

      The US Food and Drug Administration (FDA) has approved Janssen’s Rybrevant as the first treatment of patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations.
      In the US, currently available targeted treatments such as EGFR tyrosine kinase inhibitors (TKIs) are not FDA-approved for treating NSCLC driven by EGFR exon 20 insertion mutations.
      On top of that, NSCLC driven by this particular mutation often carries a worse prognosis and reduced survival rates compared with lung cancer driven by more common mutations.
      "The approval of Rybrevant, along with the companion diagnostic test, addresses high unmet need in the treatment of people with genetically defined non-small cell lung cancer," said Peter Lebowitz, global therapeutic area head, oncology, Janssen Research & Development.
      "At Janssen, we are committed to the development of innovative therapies like Rybrevant and believe that advancing medicines targeting specific pathways can bring the greatest benefits and improve outcomes for patients with tumour alterations such as EGFR and MET,” he added.
      Rybrevant, a fully-human bispecific antibody, is designed to directly target EGFR and MET receptors.
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