US biopharmaceutical company Halozyme Therapeutics Inc (NASDAQ: HALO) announced on Monday that Janssen-Cilag International NV, part of Johnson & Johnson (J&J) (NYSE:JNJ), has received European Commission marketing authorisation for the subcutaneous formulation of RYBREVANT (amivantamab) in combination with LAZCLUZE (lazertinib).

This approval covers first-line treatment of adults with advanced non-small cell lung cancer (NSCLC) harbouring EGFR exon 19 deletions or exon 21 L858R substitution mutations.

Additionally, RYBREVANT is approved as a monotherapy for patients with advanced NSCLC with EGFR exon 20 insertion mutations following failure of platinum-based therapy.

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

The approval is based on positive results from the Phase 3 PALOMA-3 trial. Halozyme noted that the new formulation reduces administration time and infusion-related reactions, potentially easing pressure on healthcare systems.

This marks the tenth approved partner product using the ENHANZE platform, according to Halozyme president and CEO Dr Helen Torley.