The subcutaneous (SC) formulation of Rybrevant, used in combination therapy with Yuhan Corp.'s Non-small cell lung cancer (NSCLC) treatment Leclaza (ingredient name Lazertinib), has received approval from the U.S. Food and Drug Administration (FDA).
Johnson & Johnson (J&J) said on the 17th (local time) that its subsidiary Janssen won FDA approval for "Rybrevant FASPRO," developed as a combination therapy using Leclaza with its anticancer drug "Rybrevant (Amivantamab)." Rybrevant FASPRO is the only subcutaneous injection therapy for patients with epidermal growth factor receptor (EGFR) mutant Non-small cell lung cancer (NSCLC).
The company expects the subcutaneous injection to cut the administration time for the existing intravenous (IV) formulation from six hours to five minutes and reduce side effects. Use of the Rybrevant–Leclaza combination therapy is projected to increase significantly.
J&J explained that administering Rybrevant FASPRO reduces infusion-related adverse reactions to 13%, one-fifth of those with the existing IV infusion (66%). The risk of venous thromboembolism is also lower with FASPRO at 11%, compared with 18% for IV infusion.