Overview
- The injection is authorized across all existing Rybrevant indications for adults with EGFR‑mutated locally advanced or metastatic non‑small cell lung cancer.
- Administration time drops from multi‑hour infusions to about five minutes, reducing clinic chair time and patient burden.
- PALOMA‑3 met co‑primary pharmacokinetic endpoints (Ctrough and AUCD1‑D15) with noninferior exposure to the intravenous regimen.
- Response rates and progression‑free survival were similar between arms, and exploratory analyses reported higher 12‑month overall survival with the subcutaneous regimen (65% vs 51%).
- Trial data showed far fewer administration‑related reactions with subcutaneous dosing versus IV, lower venous thromboembolism rates were reported, and the label retains warnings for hypersensitivity, interstitial lung disease/pneumonitis, dermatologic and ocular toxicities, and embryo‑fetal risk.