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.
Related news and insights
EQRx, Inc. a new type of pharmaceutical company committed to developing and delivering innovative medicines to patients at radically lower prices, announced that the United Kingdom (U.K.)’s Medicines and Healthcare products Regulatory Agency (MHRA) has accepted for review the marketing authorization application (MAA) for aumolertinib.
Merck Inc., announced the FDA has accepted for review a new supplemental Biologics License Application (sBLA) seeking approval for Keytruda for the adjuvant treatment of patients with stage IB ( greater than 4 centimeters), II or IIIA non-small cell lung cancer (NSCLC) following complete surgical resection.
Roche announced that the European Commission has approved Tecentriq (atezolizumab) as an adjuvant treatment, following complete resection and platinum-based chemotherapy, for adults with non-small cell lung cancer (NSCLC) with a high risk of recurrence whose tumours express PD-L1 greater than 50% and who do not have EGFR mutant or ALK-positive NSCLC.