Johnson & Johnson Introduced First and Only RYBREVANT® for Non-Small Lung Cancer
Johnson & Johnson has announced the Health Canada approval of RYBREVANT® (amivantamab for injection) in combination with carboplatin and pemetrexed for treating locally advanced or metastatic non-small cell lung cancer (NSCLC).
RYBREVANT® is a bispecific antibody targeting EGFR and MET mutations, inhibiting tumour growth and promoting cancer cell death. It has already been approved for EGFR Exon 20 insertion mutations, and this latest approval extends its use to patients with Exon 19 deletions or Exon 21 L858R mutations after osimertinib treatment. A validated test is required to confirm mutation status before treatment.
Lung cancer is the most commonly diagnosed cancer in Canada and the leading cause of cancer-related deaths. NSCLC accounts for 88% of all lung cancers in the country. Around one-third of NSCLC cases globally involve EGFR mutations, with Exon 19 deletions and Exon 21 L858R being the most prevalent.
Despite advances in targeted therapies, the five-year survival rate for advanced EGFR-mutated NSCLC remains below 20%. Patients treated with osimertinib eventually develop resistance, and chemotherapy alone has shown limited effectiveness in this group.
The approval is based on results from the Phase 3 MARIPOSA-2 clinical trial, which assessed RYBREVANT® plus platinum-based chemotherapy versus chemotherapy alone in patients previously treated with osimertinib.
The most common side effects reported included infusion-related reactions, neutropenia, nausea, rash, anaemia, thrombocytopenia, and fatigue. Serious adverse reactions, such as thrombocytopenia, dyspnoea, sepsis, and pulmonary embolism, occurred in more than 2% of patients.
Approximately 15% of patients discontinued RYBREVANT® due to adverse reactions, with infusion-related effects being the most frequent reason.
This approval marks a significant step forward in the treatment of advanced EGFR-mutated NSCLC, offering a new therapeutic option for patients with limited treatment alternatives.
