FDA Approves Exkivity for Advanced NSCLC with EGFR Exon 20 Insertion Mutation
September 16, 2021
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.Click here to read the full press release.
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