USA—Johnson & Johnson has received FDA approval for RYBREVANT® (amivantamab-vmjw) combined with LAZCLUZE™ (lazertinib) as a first-line treatment for people with locally advanced or metastatic non-small cell lung cancer (NSCLC).

This combination explicitly targets NSCLC characterized by epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as identified by an FDA-approved diagnostic test.

This is the second approval for RYBREVANT this year, based on the Phase 3 PAPILLON trial results.

In March 2024, the FDA also approved RYBREVANT® in combination with chemotherapy (carboplatin-pemetrexed) as the first-line treatment for patients with locally progressed or metastatic NSCLC with EGFR exon 20 insertion mutations.

With the approval of RYBREVANT with LAZCLUZE, it is now the first and only multitargeted, chemotherapy-free regimen that has shown superiority over osimertinib in the first-line treatment of EGFR-mutated NSCLC.

In their statement, J&J highlighted that its Phase 3 MARIPOSA research found that combining RYBREVANT and LAZCLUZE reduced the risk of disease progression or mortality by 30% compared to osimertinib alone.

In addition, its safety profile matched the known characteristics of the individual medications. However, venous thromboembolic events (VTE) were reported with the combination therapy.

In response to this development, Jill Feldman, a lung cancer survivor and co-founder of the EGFR Resisters patient advocacy group, highlighted the importance of this approval for patients with EGFR-mutated NSCLC.

Feldman noted the long-standing unmet needs within this patient population and expressed optimism about the new therapeutic options that could enhance progression-free survival benefits as demonstrated in the MARIPOSA study.

Dr. Alexander Spira, Director at the Virginia Cancer Specialists Research Institute and an investigator in the MARIPOSA study, praised the combination of RYBREVANT and LAZCLUZE for its superior efficacy.

He highlighted that this new treatment provides a potential new first-line standard of care, offering considerable clinical benefits over osimertinib.

Spira added that this targeted approach aims to optimize patient outcomes while reserving chemotherapy for more complex later stages of treatment.

Adding to this, Jennifer Taubert, Executive Vice President and Worldwide Chairman of Innovative Medicine at Johnson & Johnson, reiterated the company’s commitment to advancing oncology care.

She noted that the introduction of RYBREVANT plus LAZCLUZE sets a new benchmark in advanced first-line therapy, promising to enhance patient treatment options.

John Reed, M.D., Ph.D., Executive Vice President of Innovative Medicine, R&D at Johnson & Johnson, emphasized the company’s dedication to redefining standards of care for complex diseases like lung cancer.

He stated that the FDA approval of this chemotherapy-free regimen is a critical step towards improving survival rates and addressing the global challenge of lung cancer, the leading cause of cancer-related mortality worldwide.

With lung cancer accounting for 1.8 million deaths annually and NSCLC comprising 80 to 85 per cent of cases, the introduction of this new treatment offers hope for improved outcomes.

Despite advances, the five-year survival rate for patients with advanced EGFR-mutated NSCLC remains below 20 per cent, highlighting the ongoing need for innovative therapeutic options to combat acquired resistance mechanisms and improve treatment efficacy.

Sign up to receive our email newsletters with the latest news updates and  insights from Africa and the World HERE