Halozyme Therapeutics, Inc.announced that Janssen-Cilag International NV, a Johnson & Johnson company, has received European Commission (EC) marketing authorization of the subcutaneous (SC) formulation of RYBREVANT^® (amivantamab), in combination with LAZCLUZE^® (lazertinib), for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations. Additionally, it is approved as a monotherapy for adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after the failure of platinum-based therapy.

Subcutaneous amivantamab is co-formulated Halozyme's ENHANZE^® drug delivery technology.

"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," said Dr. Helen Torley, President and CEO of Halozyme. "The data supporting this approval showed a reduced administration time and decrease in infusion-related reactions, which could have a positive impact on the healthcare system."

The EC approval is supported by positive results from the Phase 3 PALOMA-3 study (NCT05388669). For detailed information on the study and its findings, please refer to Johnson & Johnson's press release issued today.

Leighl NB et al. Subcutaneous Versus Intravenous Amivantamab, Both in Combination With Lazertinib, in Refractory Epidermal Growth Factor Receptor–Mutated Non–Small Cell Lung Cancer: Primary Results From the Phase III PALOMA-3 Study. ASCO Journal of Clinical Oncology. 2024;42(3):3593-3605.