European Commission Approves Subcutaneous RYBREVANT® Combination For First-Line EGFR-Mutant Lung Cancer

Halozyme Therapeutics announced that Johnson & Johnson company has received European Commission approval for marketing authorisation for the subcutaneous (SC) version of RYBREVANT® (amivantamab), in combination with LAZCLUZE® (lazertinib), for first-line treatment of adults with advanced non-small cell lung cancer (NSCLC) having specific EGFR mutations. After platinum-based therapy failure, the therapy is also approved as a monotherapy for patients with advanced NSCLC carrying EGFR exon 20 insertion mutations. 

"We are delighted to announce the European approval of the subcutaneous formulation of amivantamab, developed using our innovative ENHANZE drug delivery technology. This marks our tenth approved partner product. The data supporting this approval showed a reduced administration time and decrease in infusion-related reactions, which could positively impact the healthcare system," said Dr. Helen Torley, President and CEO of Halozyme. 

This subcutaneous formulation of RYBREVANT® (amivantamab) uses Halozyme’s ENHANZE® drug delivery technology, which is more effective than intravenous delivery. The approval is based on positive findings from the Phase 3 PALOMA-3 trial, demonstrating the therapy’s effectiveness and safety.