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J&J Wins FDA Nod for Subcutaneous Version of NSCLC Drug Rybrevant
ZACKS· 2025-12-18 18:51
Core Insights - Johnson & Johnson (JNJ) has received FDA approval for the subcutaneous formulation of its EGFR/MET inhibitor, Rybrevant, now branded as Rybrevant Faspro, which is approved for all indications of the intravenous version [1][8] - The subcutaneous version offers improved patient convenience, reducing administration time from up to an hour for IV to as little as five minutes for SC [3][8] - JNJ aims to compete more effectively against AstraZeneca's Tagrisso, the current standard of care for EGFR-mutated non-small cell lung cancer (NSCLC) [4] Drug Approval and Efficacy - Both Rybrevant formulations are approved for treating non-small cell lung cancer (NSCLC) across four indications [2] - The FDA's approval was supported by data from the late-stage PALOMA-3 study, demonstrating that Rybrevant Faspro is at least as effective as the IV formulation [5][8] - The SC version utilizes Halozyme Therapeutics' proprietary drug delivery technology [6] Market Performance and Sales Goals - JNJ's stock has increased over 45% this year, outperforming the industry growth of 16% [7] - The oncology segment accounts for approximately 27% of JNJ's total revenues, with oncology sales rising nearly 21% year-over-year to $18.52 billion in the first nine months [10] - JNJ has set an ambitious target to achieve $50 billion in oncology sales by the end of the decade, needing to more than double sales from 2024 levels [12][13] Strategic Growth Initiatives - The company is expanding its oncology pipeline through acquisitions, including a recent agreement to acquire Halda Therapeutics for $3.05 billion, focusing on prostate cancer [14]