FDA Approves Exkivity as First Oral Therapy for Lung Cancer Subset

The FDA’s approval of Exkivity marks the first approved oral therapy for this subgroup of patients with non-small cell lung cancer.

The Food and Drug Administration (FDA) approved Exkivity (mobocertinib) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, whose disease progressed during or after receiving platinum-based chemotherapy, according to Takeda, the agent’s manufacturer.

“EGFR exon 20 insertion-positive NSCLC is an underserved cancer that we have been unable to target effectively with traditional EGFR (tyrosine kinase inhibitors),” said Dr. Pasi A. Jänne of the Dana Farber Cancer Institute in a news release. “The approval of (Exkivity) 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 concurrently approved Thermo Fisher Scientific’s Oncomine Dx Target Test, which identifies patients with non-small cell lung cancer that have EGFR exon 20 insertions.

The decision was based on data from the phase 1/2 trial of Exkivity, in which 114 eligible patients were treated with the drug. The researchers observed an overall response rate (ORR) – which shows the proportion of patients whose disease responds to therapy – of 28% and a median duration of response (DoR) – or the length of time a tumor responds to treatment without growing or spreading – of 17.5 months. The patients also had a median overall survival (OS) of 24 months and a median progression-free survival (PFS) of 7.3 months.

The most common side effects experienced by patients as a result of treatment with Exkivity were diarrhea, rash, nausea, stomatitis (inflamed and sore mouth), vomiting, decreased appetite, paronychia (infection surrounding the fingernail), fatigue, dry skin and musculoskeletal pain.

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Check back later to learn more about how this approval will affect patients with non-small cell lung cancer.