FDA Approves Exkivity, a Novel Oral Therapy for Lung Cancer


Takeda Oncology’s Exkivity treats non-small lung cancer in patients with EGFR exon 20 insertion mutations. This is the second approval for this mutation and the first oral therapy.

The FDA has approved Takeda Oncology’s Exkivity (mobocertinib) to treat adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 20 insertion mutations.

Exkivity, which was granted priority review and received breakthrough therapy designation, fast track designation, and orphan drug designation from the FDA, is the first approved oral therapy to target EGFR exon 20 insertion mutations.

This indication is approved under accelerated approval based on overall response rate and duration of response. The FDA approval is based on results from the platinum-pretreated population in the phase 1/2 trial of Exkivity in patients who had received prior platinum-based therapy. Results were presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting In May. In this trial, the therapy demonstrated an overall response rate of 28% as well as a median duration of response of 17.5 months, a median overall survival of 24 months.

The most common adverse reactions were diarrhea, rash, nausea, vomiting, decreased appetite, fatigue, dry skin, and musculoskeletal pain.

Pasi A. Jänne, M.D., Ph.D.

Pasi A. Jänne, M.D., Ph.D.

“EGFR exon20 insertion NSCLC is an underserved cancer that we have been unable to target effectively with traditional EGFR tyrosine kinase inhibitors,” Pasi A. Jänne, M.D., Ph.D., director of the Lowe Center for Thoracic Oncology at 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.”

At the same time, the FDA also approved Thermo Fisher Scientific’s Oncomine Dx Target Test as a companion diagnostic to identify patients who are candidates for Exkivity. The test evaluates 23 genes associated with NSCLC. The FDA first approved the test as a companion diagnostic in 2017. In the United States, it is now approved for five targeted therapies for non-small cell lung cancer and one targeted therapy for cholangiocarcinoma.

Non-small cell lung cancer is the most common form of lung cancer, accounting for about 85%. The global cancer burden is expected to be 28.4 million cases in 2040, a 47% rise from 2020, according to one estimate.Patients with EGFR exon 20 insertions make up about 1% to 2% of patients with non-small cell lung cancer.

Another therapy for exon 20 insertion mutations was approved earlier this year for this indication. In May 2021, the FDA approved Rybrevant (amivantamab-vmjw), a bispecific antibody directed against EGFR and MET receptors. Developed by Janssen, the drug is used to treat adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutation who have progressed with chemotherapy. Rybrevant, which is administered intravenously, had previously received the FDA’s priority review and breakthrough therapy designation.

At the same time, the FDA approved Guardant Health’s Guardant360 CDx liquid biopsy as a companion diagnostic.

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