CHMP grants positive opinion for J&J’s Rybrevant for lung cancer treatment

Janssen, a Johnson & Johnson (J&J) company, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended Rybrevant (amivantamab) in combination with chemotherapy.
CHMP has recommended the approval of the drug for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) exon 20 insertion mutations.
This recommendation is based on results from the PAPILLON study, which met its primary endpoint, proving a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in patients being treated with Rybrevant plus chemotherapy compared to chemotherapy alone.
Henar Hevia, senior director, EMEA therapeutic area lead in Oncology at J&J Innovative Medicine, commented: “Lung cancer remains the leading cause of cancerrelated mortality in Europe. As patients living with EGFR exon 20 insertion-mutated NSCLC face a particularly poor prognosis, the need for innovative combinations in the frontline setting is vital. At J&J, we are dedicated to the development and delivery of novel, targeted therapies aimed to address specific disease pathways, with the ultimate goal of ensuring each patient receives the right treatment at the right time.”
Kiran Patel MD, vice president of clinical development in solid tumours at J&J Research & Development, added: “Today’s positive opinion represents the culmination of years of work and our team’s commitment to the lung cancer community. We will continue to focus on redefining treatment paradigms, starting from the very first line of therapy, with a goal of improving survival rates and overall patient outcomes. Through our extensive research and development efforts, we are pioneering novel approaches and targeting key pathways implicated in lung cancer progression, with the ultimate goal of transforming clinical outcomes for patients with EGFR-mutated NSCLC.”
Professor Nicolas Girard, head of Medical Oncology, Institut Curie, and professor of Thoracic Oncology and Respiratory Medicine at the Paris Saclay University, France, stated: “The PAPILLON study results represent an important advancement in the EGFR exon 20 insertion NSCLC treatment landscape, demonstrating significantly improved progression-free survival with first-line amivantamab plus chemotherapy, versus chemotherapy alone. Notably, we observed improvements in functional status and reduction in lung cancer-related symptoms, underscoring the potential of this regimen to redefine standards of care for these patients, offering hope for improved quality of life and patient-relevant treatment outcomes.”