FX.co ★ Halozyme Says CHMP Recommends Approval Of Subcutaneous Rybrevant Developed With ENHANZE In NSCLC

Janssen-Cilag International NV, a subsidiary of Johnson & Johnson, has received a recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) to extend the marketing authorization for a new subcutaneous formulation of Rybrevant. This formulation, developed in collaboration with Halozyme Therapeutics, Inc. (HALO), is intended for use in combination with Lazcluze for the treatment of advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations. Rybrevant utilizes Halozyme's innovative ENHANZE drug delivery technology. The positive opinion from CHMP is based on encouraging outcomes from the Phase 3 PALOMA-3 study.