Janssen Submits Marketing Authorisation Application to the European Medicines Agency Seeking Approval of Lazertinib, in combination with RYBREVANT (amivantamab), for the First-Line Treatment of Patients with EGFR-Mutated Non-Small Cell Lung Cancer
December 21, 2023 – Clinical Trials – EMA, Janssen, NSCLC
The submission is supported by data from the Phase 3 MARIPOSA study, which featured in a Late-Breaking Presidential Symposium session at the 2023 ESMO Congress
Lazertinib is a highly selective, central nervous system-penetrant, third-generation EGFR tyrosine kinase inhibitor
21 December 2023 — Beerse, Belgium — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a marketing authorisation application (MAA) to the European Medicines Agency (EMA) seeking approval of lazertinib, in combination with RYBREVANT (amivantamab), for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with common epidermal growth factor receptor (EGFR) mutations including exon 19 deletions (ex19del) or exon 21 L858R (L858R) substitution mutations.
“Despite significant advances in the treatment of EGFR-mutated NSCLC, the progression-free survival (PFS) rate with the current first-line therapies remains low,” said Catherine Taylor, vice president of EMEA Medical Affairs, Therapy Area Strategy, Janssen-Cilag AG. “Novel targeted therapies are necessary to address resistance and disease progression, and provide new options for patients in this area of high unmet medical need.”
MARIPOSA (NCT04487080) is a randomised, phase 3 study evaluating amivantamab in combination with lazertinib compared to osimertinib in the first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR ex19del or L858R substitution mutations. The MARIPOSA study met its primary endpoint, resulting in statistically significant and clinically meaningful improvement in PFS for amivantamab plus lazertinib versus osimertinib, as assessed by blinded independent central review (BICR). The safety profile of amivantamab plus lazertinib was consistent with prior reports of the combination, with mostly Grade 1 or 2 adverse events (AEs).
“Lung cancer remains the leading cause of cancer death worldwide and high unmet needs remain for patients with certain oncogenic driver mutations,” said Kiran Patel MD, vice president of Clinical Development, Solid Tumours, Janssen Research and Development, LLC. “We’re pleased to announce the submission of lazertinib, in combination with amivantamab as a chemotherapy-free regimen, in the first-line, common EGFR-mutated NSCLC setting, to the EMA. Once again, this shows our commitment to advancing innovative therapies that have the potential to be a future standard of care.”
The pivotal data from the MARIPOSA study were featured in a Late-Breaking Presidential Symposium session (Abstract #LBA14) at the 2023 European Society of Medical Oncology (ESMO) Congress.
About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension and Retina. Learn more at www.janssen.com/emea.
