(CercleFinance.com) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that it has applied to the FDA to seek expanded approval for Rybrevant® (amivantamab-vmjw) in combination with chemotherapy (carboplatin-pemetrexed) for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations.
Following US FDA Breakthrough Therapy Designation in 2020, Rybrevant® had received accelerated approval in 2021 as a treatment for NSCLC patients with EGFR exon 20 insertion mutations.
This new application presents ‘an opportunity to dramatically improve the standard of care for this patient population with significant unmet medical needs’, said Kiran Patel, vice president of clinical development, solid tumors, Janssen Research & Development.
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