Johnson & Johnson Touts Rybrevant Label Expansion After Rare Lung Cancer Approval

  • Janssen, a unit of Johnson & Johnson JNJ, announced preliminary data from the Phase 1 CHRYSALIS study evaluating Rybrevant (amivantamab-vmjw) for non-small cell lung cancer (NSCLC) with mesenchymal-epithelial transition (MET) exon 14 skipping (METex14) mutations.
  • A total of 19 patients with METex14 mutations received either a high or low dose of Rybrevant, and 14 of them were evaluable. Of that 14 patients, partial responses were observed in 64%, with four patients pending confirmation.
  • The responses were seen in both patients who had and hadn’t received prior treatment, and the median time to first response was 4.1 months.
  • Three patients experienced serious side effects of the treatment, including difficulty breathing, hypoalbuminemia (a deficit of albumin in the blood), and rash. 
  • About 5% of patients discontinued the treatment due to side effects.
  • In May, regulators gave Rybrevant an accelerated thumbs-up for a rare form of lung cancer, making it the first drug approved to treat patients with EGFR exon 20 insertion mutations.
  • Related content: Benzinga's Full FDA Calendar. 
  • Price Action: JNJ shares are up 0.65% at $178.35 during the market session on the last check Thursday.
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Posted In: BiotechNewsHealth CareFDAGeneralBriefsNon-Small Cell Lung CancerPhase 1 Trial
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