CHMP recommends Rybrevant to treat NSCLC with activating epidermal growth factor receptor (EGFR) exon 20 insertion mutations.-Janssen International N.V.
The applicant for this medicinal product is Janssen-Cilag International N.V.
Rybrevant will be available as a 350 mg concentrate for solution for infusion. The active substance of Rybrevan is amivantamab, a fully human IgG1-based EGFR MET bispecific antibody that targets tumours with activating EGFR exon 20 insertion mutations (ATC code: L01FX18).
The benefits of Rybrevant are its objective response rate and response duration in NSCLC patients with EGFR exon 20 insertion mutations after failure of platinum?based therapy. The most common side effects are rash, infusion related reactions, nail toxicity, hypoalbuminemia, oedema, fatigue, stomatitis, nausea, and constipation.
150 mins
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