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FDA to Review Applications for Potential Approval of Rybrevant for NSCLC Subset


The pharmaceutical company submitted applications for the FDA to consider approval of Rybrevant plus lazertinib for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer with EGFR exon 19 deletions or L858 substitution mutations.


Johnson & Johnson is seeking approval from the Food and Drug Administration (FDA) for Rybrevant (amivantamab-vmjw) with lazertinib via two separate applications for the first-line treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or L858R substitution mutations.

In particular, the company submitted a supplemental biologics license application and a new drug application to the FDA, according to a press release from Johnson & Johnson, the manufacturer of Rybrevant.

“The combination of Rybrevant and lazertinib demonstrated statistically significant and clinically meaningful improvement in progression-free survival compared to osimertinib (Tagrisso) in patients with previously untreated EGFR-mutated NSCLC,” Dr. Kiran Patel, vice president of clinical development in solid tumors at Johnson & Johnson Innovative Medicine, said in the release. “This remains an area of high unmet need, as patients often experience treatment resistance and disease progression on currently available therapies.”

Both applications are supported by findings from the phase 3 MARIPOSA trial, which were recently presented at the European Society of Medical Oncology 2023 Congress. When compared with Tagrisso, Rybrevant plus lazertinib resulted in a 30% reduction in the risk for disease progression or death in patients with locally advanced or metastatic NSCLC with either EGFR exon 19 deletions or L858R substitution, according to a separate press release from Johnson & Johnson announcing results of this study.

The median progression-free survival (the time during and after treatment when a patient with cancer is alive without the disease worsening) at a median follow-up of 22 months was 23.7 months in patients assigned Rybrevant plus lazertinib compared with 16.6 months in those assigned Tagrisso.

Patients in the MARIPOSA trial assigned Rybrevant plus lazertinib also obtained an overall survival (the time from the start of treatment when a patient with cancer is still alive) benefit versus those treated with Tagrisso.

“We believe this targeted, chemotherapy-free regimen may have the potential to transform the treatment of EGFR-mutated NSCLC, and we look forward to working with the FDA in review of these applications,” Patel said in the release.

When a biologics license application is submitted to the FDA, a pharmaceutical company is requesting permission to introduce or deliver a particular biologic product — in this case, Rybrevant — into commerce, according to the FDA’s website.

A new drug application is the method by which pharmaceutical companies formally propose to the FDA that their drug should be considered for approval in the U.S. Several decisions are made by the FDA based on this application including whether the drug’s labeling is appropriate and what it should contain, whether the drug is effective and safe for its proposed use, and whether the manufacturing process for the drug can maintain its quality, according to the FDA’s website.

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