Approvals

CHMP has recommended the approva l 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 Oncoogy at J&J Innovative Medicine, commented: “Lung cancer remains the leading cause of cancer-related 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 deliver y 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.”

Trial investigator professor Nicolas Girard, head of Medical Oncology at the Institut Curie, and Professor of Thoracic Oncology and Respirator y Medicine at the Paris Saclay University, both 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 obser ved 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.”