On September 15, 2021, the FDA accelerated the approval of Exkivity (mobocertinib; from Takeda), an oral kinase inhibitor, for the treatment of adults with locally advanced or metastatic (spreading) non–small-cell lung cancer (NSCLC) and EGFR exon 20 insertion mutations (as detected by an FDA-approved test), whose disease progressed during or after platinum-based chemotherapy.
On the same day, the FDA also approved the Oncomine Dx Target Test as a companion diagnostic test for the identification of patients who are candidates to receive treatment with Exkivity.
“EGFR Exon 20 insertion-positive NSCLC is an underserved cancer that we have been unable to target effectively with traditional EGFR TKIs,” Pasi A. Jänne, MD, PhD, of Dana-Farber Cancer Institute, said in a statement. “The approval of Exkivity (mobocertinib) marks another important step forward that provides physicians and their patients with a new targeted oral therapy specifically designed for this patient population that has shown clinically meaningful and sustained responses.”
The FDA approved Exkivity based on Study 101, an international clinical trial of 114 patients with locally advanced or metastatic NSCLC and EGFR exon 20 insertion mutations, whose disease progressed during or after platinum-based chemotherapy. Patients received Exkivity capsules daily until disease progression or intolerable side effects.
The overall response rate with Exkivity was 28%, and the responses lasted on average for 17.5 months.
The most common side effects with Exkivity were diarrhea, rash, nausea, stomatitis, vomiting, decreased appetite, paronychia, fatigue, dry skin, and musculoskeletal pain.
In May 2021, the FDA approved the first targeted therapy—Rybrevant (amivantamab-vmjw)—for patients with NSCLC and EGFR exon 20 insertion mutations. More information on this approval is available at https://tinyurl.com/4y3ehkvt.