Subcutaneous amivantamab Biologics License Application submitted to U.S. FDA for patients with EGFR-mutated non-small cell lung cancer [Yahoo! Finance]
Johnson & Johnson (JNJ)
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Source: Yahoo! Finance
Longer overall survival, progression-free survival and duration of response also observed with subcutaneous amivantamab RARATIN, N.J. June 17, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for a fixed combination of amivantamab and recombinant human hyaluronidase for subcutaneous administration (SC amivantamab) for all currently approved or submitted indications of intravenous (IV) RYBREVANT ® (amivantamab-vmjw) in certain patients with non-small cell lung cancer (NSCLC). Data from the Phase 3 PALOMA-3 study ( NCT05388669 presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the Journal of Clinical Oncology showed SC amivantamab had comparable overall response rates to IV administration in patients with NSCLC with epidermal growth factor receptor (EGFR) exon 19 deletion or L858R mutations. SC amivantamab also demo
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JNJ
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- 4/16/24 - Beat
JNJ
Sec Filings
- 6/25/24 - Form 11-K/A
- 6/24/24 - Form 11-K
- 6/24/24 - Form 11-K
- JNJ's page on the SEC website