J&J Wins FDA Nod for Subcutaneous Version of NSCLC Drug Rybrevant (Revised)

Core Insights - Johnson & Johnson (JNJ) has received FDA approval for the subcutaneous formulation of its EGFR/MET inhibitor, Rybrevant, now marketed as Rybrevant Faspro, which is approved for all indications of the intravenous version [1][8] Group 1: Product Approval and Advantages - Both Rybrevant and Rybrevant Faspro are approved in the U.S. for four indications related to EGFR-mutated non-small cell lung cancer (NSCLC), including two first-line and two second-line settings [2] - The subcutaneous formulation offers significant advantages in patient convenience, reducing administration time to about five minutes compared to several hours for the intravenous version [3][8] - The approval of Rybrevant Faspro is supported by data from the late-stage PALOMA-3 study, demonstrating its effectiveness compared to the IV formulation [5][8] Group 2: Competitive Landscape - With this approval, JNJ is better positioned to compete with AstraZeneca's Tagrisso, the current standard of care for EGFR-mutated NSCLC, although Tagrisso's oral administration remains a competitive advantage [4] Group 3: Oncology Sales and Growth Strategy - JNJ's oncology segment comprises approximately 27% of total revenues, with oncology sales rising nearly 21% year-over-year to $18.52 billion in the first nine months [10] - The company aims to achieve $50 billion in oncology sales by the end of the decade, having doubled its oncology sales from $10.7 billion in 2019 to $20.8 billion in 2024 [12] - JNJ is actively building its oncology pipeline through acquisitions, including a recent agreement to acquire Halda Therapeutics for $3.05 billion to enhance its prostate cancer portfolio [14]