Health Canada approval of Rybrevant, the first and only targeted treatment for non-small cell lung cancer with EGFR Exon 20 insertion mutations.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced that Health Canada has issued a Notice of Compliance with Conditions (NOC/c) approving Rybrevant(amivantamab), a fully-human, bispecific antibody, for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal-growth factor receptor (EGFR) Exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.
Health Canada NOC/c is granted to promising new therapies for patients diagnosed with serious, life-threatening or severely debilitating diseases, conditions for which no drug is currently marketed in Canada, or for which a significant increase in efficacy or significant decrease in risk is demonstrated in relation to existing drugs marketed in Canada. This conditional approval is pending the results of trials to verify its clinical benefits.
Lung cancer is the leading cause of cancer death among men and women in Canada, accounting for almost 25 per cent of all cancer deaths. More people die from lung cancer in Canada than breast, colorectal and prostate cancers combined.