Johnson & Johnson has receieved US Food & Drug Administration (FDA) approval for its combination therapy designed as a first-line treatment for adults with non-small cell lung cancer.
Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) can be used in adult patients with locally advanced or metastatic iterations of NSCLC who have EGFR exon 19 deletions, or exon 21 L858R substitutions.
Through this regulatory approval, Rybrevant plus Lazcluze becomes the first chemotherapy-free combination regimen for patients that has demonstrated superiority when compared to osimertinib.
The treatment regimen is multitargeted, and can work to modulate both of the EGFR mutations commonly associated with the disease.
"This approval is a crucial development for patients with EGFR-mutated NSCLC, who have faced significant unmet needs for far too long," said Jill Feldman, the co-founder of the EGFR Resisters, a patient advocacy group.
"Having witnessed firsthand the remarkable evolution in lung cancer treatment, this profoundly important milestone brings a novel therapeutic approach to patients and their families."
The approval stems from the positive results observed in the Phase III MARIPOSA study, which found that Rybrevant plus Lazcluze reduced the risk of disease progression or death by 30% when compared to osimertinib.
The overall patient median duration of response was also nine months longer than for osimertinib alone.
"The combination of Rybrevant and Lazcluze demonstrated superior efficacy in the first-line treatment of certain patients with EGFR-mutated advanced NSCLC as shown with the MARIPOSA study," said Alexander Spira, Director of the Virginia Cancer Specialists Research Institute, and study investigator.
"Patients will now have the option of a potential new first-line standard of care with significant clinical benefits over osimertinib. This first-line therapy uses a targeted approach aiming to achieve the best possible patient outcomes while reserving chemotherapy for later stages of treatment when resistance becomes more complex."