On August 19, 2024, the US Food and Drug Administration (FDA) approved a new treatment option for people newly diagnosed with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations.
The recent approval offers a new chemotherapy-free treatment for patients—the combination of lazertinib (Lazcluze™) with amivantamab-vmjw (Rybrevant®).
Prior to this approval, treatment with osimertinib (Tagrisso®) alone or in combination with chemotherapy was the gold standard for treating this population.
Lazertinib is given as an oral pill. It is a tyrosine kinase inhibitor (TKI) that targets the T790M EGFR mutation and the activating EGFR mutations (exon 19 deletions or exon 21 L858R).
Amivantamab is given through an IV infusion. It is categorized as a “bispecific monoclonal antibody,” which means that it can target two different proteins at once. In this case, it can target EGFR and MET.
The FDA’s approval of this combination therapy is based on the results of the MARIPOSA phase III clinical trial, which demonstrated that the combination of lazertinib with amivantamab extended the time in which the cancer isn’t growing or spreading (median progression-free survival) by about 7 months. The trial enrolled 1,074 patients globally, including in Australia, Brazil, Canada, and Switzerland.
It’s important to note that some patients on this treatment experienced significant side effects. Patients and caregivers are encouraged to discuss all treatment options with their healthcare provider.
In 2021, amivantamab was approved for the treatment of advanced NSCLC with EGFR exon20 insertion mutations by the FDA.
Learn more information about this FDA approval, including important information about side effects.
If you have EGFR+ lung cancer, the LUNGevity EGFR Patient Gateway has more information about available treatments, finding a specialist, clinical trials, online support groups, and more.