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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The agency granted Rybrevant (amivantamab-vmjw) Breakthrough Therapy Designation (BTD) in March 2020 and prioritized its review of the Biologics License Application for the drug in December 2020.
Lung cancer is the most common cause of cancer mortality for both men and women. For 2021, NIH estimates that there will be 235,760 lung cancer cases, equating to 12.4% of new cancer cases but 21.7% of cancer deaths.