On September 15th, 2021, the Food and Drug Administration (FDA) approved Exkivity (mobocertinib) for treatment of advanced non-small cell lung cancer (NSCLC) with a change in EGFR called exon 20 insertion. The FDA based their approval on the results of a clinical trial which showed that patients receiving Exkivity responded to the drug for over a year.
In addition to approving Exkivity, the FDA also granted approval for Oncomine Dx Target Test as a companion diagnostic. Exkivity marks only the second drug to receive approval from the FDA for patients with the exon 20 insertion change delivering hope and another option to a large population of patients.
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