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Mobocertinib approved as first oral therapy for EGFR Exon20+ NSCLC

September 16, 2021


Takeda have announced that the US Food and Drug Administration (FDA) has 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, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

The FDA simultaneously approved Thermo Fisher Scientific’s Oncomine Dx Target Test as an next generation sequencing (NGS) companion diagnostic for mobocertinib to identify NSCLC patients with EGFR Exon20 insertions. NGS testing is critical for these patients as it can enable more accurate diagnoses compared to polymerase chain reaction (PCR) testing, which detects less than 50 percent of EGFR Exon20 insertions.

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