Halozyme (HALO) announced that Janssen-Cilag International, a Johnson & Johnson (JNJ) company, received a positive opinion from the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, recommending an extension of marketing authorisation for a subcutaneous formulation of Rybrevant in combination with Lazcluze for the first-line treatment of adult patients with advanced non-small cell lung cancer ,or NSCLC, with epidermal growth factor receptor exon 19 deletions or exon 21 L858R substitution mutations, and as a monotherapy for the treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after failure of platinum-based therapy. The CHMP positive opinion is supported by positive results from the Phase 3 PALOMA-3 study. Subcutaneous amivantamab is co-formulated with recombinant human hyaluronidase PH20, Halozyme’s Enhanze drug delivery technology.
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