Janssen seeks expanded USFDA approval for Rybrevant in combination with chemotherapy
Raritan: The Janssen Pharmaceutical Companies of Johnson & Johnson has announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking the expanded approval of RYBREVANT (amivantamab-vmjw) in combination with chemotherapy (carboplatin-pemetrexed) for the first-line treatment of patients with locally...
Raritan: The Janssen Pharmaceutical Companies of Johnson & Johnson has announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking the expanded approval of 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. The sBLA is being reviewed by the FDA through the Real-Time Oncology Review (RTOR) program.
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