sBLA is submitted to the FDA seeking approval of Rybrevant (amivantamab-vmjw) + chemotherapy to treat EGFR-mutated non-small cell lung cancer which progressed on or after osimertinib.- Janssen Pharmaceutical Companies.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the FDA seeking the approval of Rybrevant (amivantamab-vmjw) in combination with chemotherapy (carboplatin and pemetrexed) for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution after disease progression on or after osimertinib.
This application is supported by data from the Phase III MARIPOSA-2 (NCT04988295) study evaluating the efficacy and safety of Rybrevant and chemotherapy in patients with locally advanced or metastatic EGFR ex19del or L858R substitution NSCLC who had disease progression on or after treatment with osimertinib. Results from the MARIPOSA-2 study were recently presented in a Presidential Symposium at the European Society of Medical Oncology (ESMO) 2023 Congress (Abstract #LBA15) and simultaneously published in the Annals of Oncology.
See- "Amivantamab plus chemotherapy with and without lazertinib in EGFR-mutant advanced NSCLC after disease progression on osimertinib: primary results from the phase III MARIPOSA-2 study"-A. Passaro , J. Wang , Y. Wang, R.G. Campelo , B.C. Cho . for the MARIPOSA-2 Investigators Open Access.Published:October 23, 2023DOI:https://doi.org/10.1016/j.annonc.2023.10.117.
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