EC Approves Johnson & Johnson’s Rybrevant for First-Line NSCLC

Johnson & Johnson’s (J&J) Rybrevant (amivantamab) has received approval from the European Commission (EC) for initial use in treating non-small cell lung cancer (NSCLC). This bispecific antibody is now authorised to be used in conjunction with carboplatin and pemetrexed chemotherapy for adults with advanced NSCLC characterized by epidermal growth factor receptor (EGFR) exon 20 insertion mutations.

Previously, in December 2021, the EC had granted conditional marketing authorisation for Rybrevant for patients with the same mutation after the failure of platinum-based therapy. This conditional approval has now been converted into a standard marketing authorisation. The latest approval by the EC was driven by positive outcomes from the late-stage PAPILLON study. The study demonstrated that Rybrevant combined with chemotherapy significantly improved progression-free survival compared to chemotherapy alone. An interim analysis of overall survival also indicated a positive trend for patients receiving the combination treatment.

According to Nicolas Girard, a trial investigator from Institut Curie and Paris Saclay University, Rybrevant has already proven its efficacy in second-line treatment settings. With this new approval for first-line treatment, the combination of Rybrevant and chemotherapy could potentially redefine the standard of care for patients, enhancing both clinical efficacy and quality of life.

Non-small cell lung cancer represents up to 85% of all lung cancer cases. Alterations in EGFR are the most common actionable driver mutations in this disease. J&J highlighted the grave prognosis for patients with EGFR exon 20 insertion mutations, citing real-world five-year survival rates as low as 8%. This underscores the necessity for novel targeted therapies that address the specific complexities of EGFR exon 20 insertion mutations.

Henar Hevia, Senior Director and EMEA Therapeutic Area Lead in Oncology at J&J Innovative Medicine, hailed the approval as a significant advancement for patients with EGFR exon 20 insertion-mutated NSCLC. Hevia emphasized that these patients could now benefit from Rybrevant combined with chemotherapy at the beginning of their treatment journey.

On the same day as the Rybrevant approval, J&J also announced that it had received a recommendation from the European Medicines Agency’s human medicines committee for the use of Balversa (erdafitinib). This recommendation is for a once-daily oral monotherapy aimed at specific cases of urothelial carcinoma.