Johnson & Johnson (J&J; NYSE: JNJ) subsidiary Janssen has submitted an additional indication for review with the US Food and Drug Administration (FDA) for its bispecific antibody (BsAb) Rybrevant (amivantamab). The submission seeks approval for Rybrevant in combination with carboplatin and pemetrexed as a first-line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations. This follows the product’s 2021 accelerated approval for NSCLC with EGFR exon 20 insertion mutations, which will be further supported by clinical benefit data from the recent submission.
Real-Time Oncology Review (RTOR) Pathway
The filing will be processed through the real-time oncology review (RTOR) pathway, an expedited review process that allows components of an application to be reviewed before the submission of the complete dossier. This approach can significantly shorten the review timeline and expedite the availability of new treatments for patients.
Supporting Data from Late-Stage Trial
The submission is backed by results from a late-stage trial that met its primary endpoint of achieving significant and meaningful improvement in progression-free survival (PFS) for the combination therapy compared to chemotherapy alone. This data supports the potential efficacy of Rybrevant in improving outcomes for patients with NSCLC and underscores the importance of its potential expanded indication.-Fineline Info & Tech
