The FDA has approved J&Js Rybrevant plus Lazcluze to treat patients with certain types of NSCLC. Credit: Nattakorn_Maneerat via Shutterstock.

Johnson & Johnson’s (J&J) Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) has secured US Food and Drug Administration (FDA) approval as a first-line treatment for patients with some types of non-small cell lung cancer (NSCLC).

The indication covers patients with locally advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.

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The approval is based on data from the Phase III MARIPOSA study (NCT04487080), which compared the Rybrevant/Lazcluze combination to AstraZeneca’s Tagrisso (osimertinib). Data showed that Rybrevant plus Lazcluze reduced the risk of disease progression or death by 30% compared to Tagrisso alone. Additionally, the median duration of response was nine months longer with the combination therapy compared to Tagrisso.

The study met its primary endpoint of progression-free survival (PFS) and additional secondary endpoints, including participant race, type of EGFR mutation, and history of brain metastasis. These findings demonstrated clinically meaningful benefits of the combination treatment over Tagrisso.

J&J filed a supplemental biologics licence (sBLA) and a new drug application (NDA) to the FDA in this indication back in December 2023. The FDA approved Rybrevant in combination with carboplatin-pemetrexed chemotherapy for its use as a first-line treatment of locally advanced or metastatic NSCLC harbouring EGFR exon 20 insertion mutations in March 2024.

J&J said the drug combination is now the first and only multitargeted, chemotherapy-free combination regimen with demonstrated superiority over Tagrisso.

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This approval could mean competition for AstraZeneca. Both Rybrevant and Tagrisso target and inhibit specific mutations in the EGFR gene, a common target in NSCLC. Tagrisso pulled in $5.8bn last year in sales. According to GlobalData’s Pharma Intelligence Center, Rybrevant is forecast to generate $3.9bn in 2030, with Tagrisso projecting higher sales at $7.7bn in the same year.

In the announcement accompanying the approval, J&Js executive vice president Jennifer Taubert said: “Building on more than three decades of oncology innovation, we are uniquely positioned to build best-in-class treatments where survival rates have remained stagnant for years. Rybrevant plus Lazcluze establishes a new benchmark in the advanced first-line setting, and we look forward to bringing this new chemotherapy-free treatment regimen to patients.”