Takeda Pharmaceutical Co. Ltd. becomes the first one to get FDA approval for an oral drug targeted against rare form of non-small cell lung cancer. FDA has approved Exkivity (mobocertinib) for treatment of adult patients with locally advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease has progressed during or after receiving chemotherapy.
Dr. Pasi A. Jänne of the Dana Farber Cancer Institute said, “EGFR exon 20 insertion-positive NSCLC is an underserved cancer that we have been unable to target effectively with traditional EGFR (tyrosine kinase inhibitors).” “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,” he added.
This drug is designed to treat patients who have a mutated protein that can cause rapid cell growth. Mobocertinib is an oral tyrosine kinase inhibitor specially designed to target EGFR exon 20 insertion mutations. These patients are about 2%- 3% of all people diagnosed with non-small cell lung cancer. As per the terms of approval, Exon 20 insertion mutations must be detected by an FDA-approved test. This approval introduces a new treatment option for those with EGFR exon 20 insertion+ NSCLC. Exkivity oral therapy specifically targets those insertions.
At the same time as mobocertinib was approved, Oncomine Dx Target Test by Thermo Fisher Scientific was also approved. This will work as a companion diagnostic designed to identify NSCLC patients with EGFR exon 20 insertions. This approval received by Takeda is based on Phase 1/2 trial results which demonstrated clinically meaningful responses with a median duration response of about 1.5 years.
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