2021: New EGFR Lung Cancer Drug

On This Day in Health: May 21, 2021

On May 21, 2021, the U.S. Food and Drug Administration granted accelerated approval to amivantamab, marketed as Rybrevant, for a defined group of adults with advanced non-small cell lung cancer. Their tumors had to carry EGFR exon 20 insertion mutations, identified by an FDA-approved test, and their disease had to have progressed during or after platinum-based chemotherapy. The decision addressed a molecularly distinct treatment problem rather than all lung cancer. It also came with approval of a companion diagnostic, emphasizing that finding the relevant tumor feature was part of identifying the people for whom the medicine could be considered.

EGFR is involved in signals that influence cell growth. Different alterations in the same gene can create different clinical challenges, so an EGFR result cannot always be treated as a single interchangeable category. Amivantamab is a bispecific antibody directed against EGFR and MET receptors. The 2021 approval connected that drug design to the exon 20 insertion population studied in the clinical program. Its significance rested on the match between the biological feature, the evidence and the treatment history. For patients, that match made the diagnostic report a practical part of the care discussion, rather than simply an additional description of the cancer.

The supporting CHRYSALIS trial included an efficacy group of 81 patients whose disease had progressed after platinum-based chemotherapy. The FDA reported an overall response rate of 40 percent and examined the duration of those responses. This evidence supported accelerated approval, with further studies needed to verify clinical benefit. It was not a demonstration that every tumor would shrink or that the medicine would permanently control the disease. Infusion-related reactions and rash were among the important adverse effects reported at the time. The treatment was delivered intravenously by a clinical team, so its use involved appointments, preparation and attention to reactions as well as the decision to prescribe it.

May 21 illustrates how a narrower definition of disease can create a more useful treatment opportunity. Two people may have cancers arising in the same organ but require different options because of their tumor's molecular features. The approval made that principle concrete for a group facing progression after chemotherapy. It also showed why an anniversary should preserve the original indication instead of borrowing later expansions of a medicine's use. In 2021, the achievement was the addition of an option for this specific previously treated population. Remembering it means recognizing both the scientific work behind the antibody and the testing, clinical judgment and follow-up required to translate that work into care.