Janssen Announces Health Canada Approval of RYBREVANT ® (amivantamab), the First and Only Targeted Treatment for Patients with Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

Toronto, ON, April 4, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today 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.[i] 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.[ii] This conditional approval is pending the results of trials to verify its clinical benefits.[i] 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.[iii] More people die from lung cancer in Canada than breast, colorectal and prostate cancers combined.[iv]An estimated 15 per cent of Canadians with non-squamous NSCLC have an activating EGFR mutation.[v] The frequency of EGFR mutations is even greater in patients of Asian descent (~39 per cent) and in Asia-Pacific countries (~47 per cent).[vi],[vii] Those with the third most prevalen...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news