On September 15, 2021, Thermo Fisher Scientific announced that the U.S. Food and Drug Administration (FDA) has granted pre-market approval to Thermo Fisher Scientific's Oncomine Dx Target Test as a companion diagnostic (CDx) to identify patients with epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive metastatic non-small cell lung cancer (mNSCLC) who are candidates for EXKIVITY™ (mobocertinib), a targeted drug developed by Takeda Pharmaceutical Company Limited. EXKIVITY is a small-molecule tyrosine kinase inhibitor (TKI) designed to selectively target EGFR Exon20 insertion mutations. It received approval by the FDA on September 15, 2021 for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (mNSCLC) with EGFR Exon20 insertion mutations as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. This indication is approved under Accelerated Approval based on overall response rate and duration of response demonstrated in the platinum-pretreated population of the Phase 1/2 trial of EXKIVITY. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
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