Johnson & Johnson announced Tuesday that the FDA has approved Rybrevant with Lazcluze as a first-line chemotherapy-free treatment for patients with EGFR-mutated non-small cell lung cancer.
Johnson & Johnson has won FDA approval for its chemotherapy-free regimen for a type of non-small cell lung cancer. The green light offers patients a new first-line standard of care option, the company announced Tuesday.
The regimen combines J&J’s bispecific antibody Rybrevant with Lazcluze, an oral brain-penetrant EGFR tyrosine kinase inhibitor, for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that carry specific epidermal growth factor receptor (EGFR) mutations.
According to J&J, it’s the first and only multitargeted, chemotherapy-free combination treatment “with demonstrated superiority versus osimertinib approved for the first-line treatment of patients with EGFR-mutated NSCLC.”
Rybrevant and Lazcluze were pitted against AstraZeneca’s Tagrisso (osimertinib), which is commonly used in first-line treatment following chemotherapy in NSCLC patients with the same mutations. In the Phase III MARIPOSA study, J&J’s combo reduced risk of disease progression or death by 30% compared to Tagrisso. Median duration of response was nine months longer in the Rybrevant group as well. Safety profiles were consistent with the individual treatments.
“This approval is a crucial development for patients with EGFR-mutated NSCLC, who have faced significant unmet needs for far too long,” Jill Feldman, lung cancer survivor and co-founder of patient advocacy group EGFR Resisters, said in a statement.
NSCLC accounts for the majority of cancer deaths worldwide—80% to 85%—with around 10% to 15% of those cases carrying the EGFR mutation. For those patients with the mutation, up to 39% never receive second-line therapy due to rapid disease progression.
Tuesday’s win builds on a prior approval in March 2024 when the FDA granted full approval for a Rybrevant-chemo combo for NSCLC with exon 20 insertion mutations. The treatment previously received accelerated approval after the regimen cut risk of disease progression or death by 60% versus chemotherapy alone.
A second trial, dubbed MARIPOSA-2, revealed data that showed Rybrevant significantly improved progression-free survival in patients who had progressed after Tagrisso, with or without Lazcluse. The FDA is now reviewing an application to approve a subcutaneous administration of Rybrevant.
Rybrevant is projected to generate $4 billion in sales by 2030, according to data analytics firm GlobalData.
