Janssen seeks USFDA nod for Rybrevant plus chemotherapy for patients with EGFR-Mutated Non-Small Cell Lung Cancer who progressed on or after Osimertinib

“New treatment options are urgently needed in the post-osimertinib setting, where patients continue to face unacceptable survival rates,” said Kiran Patel, M.D., Vice President, Clinical Development, Solid Tumors, Janssen Research & Development, LLC.

“As we strive to transform the standard of care in patients with EGFR-mutated NSCLC, we are committed to working closely with the FDA during review of this submission for RYBREVANT in this expanded patient population.”

This application is supported by data from the Phase 3 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.

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