Rybrevant, a novel fully-human bispecific antibody from the Janssen division of Johnson & Johnson, became the first treatment for people with non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 20 insertion mutations. In particular, the indication covers such cancer that has progressed on or after platinum-based chemotherapy.
The agency also approved the Guardant360 CDx from Guardant Health as a companion diagnostic for Rybrevant.
“Advances in precision oncology continue to facilitate drug development, allowing diseases like lung cancer to be subset into biomarker-defined populations appropriate for targeted therapies,” said Dr. Julia Beaver, chief of medical oncology in the FDA’s Oncology Center of Excellence, in a statement. “With today’s approval, for the first time, patients with non-small cell lung cancer with EGFR exon 20 insertion mutations will have a targeted treatment option.”
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