Takeda Voluntarily Withdraws U.S. Indication for EGFR Exon20 Inhibitor Exkivity in First-Line NSCLC Treatment-VCBeat

On October 2, Takeda announced that it would voluntarily withdraw after discussions with the FDA.EGFR Exon20 Inhibitor Exkivity (Mobocertinib,Mobocertinib) US Indications, i.e.First-line treatment for EGFR exon 20 (Exon20) Insertion mutation in non-small cell lung cancer (NSCLC).

ExkivityIn September 2021Based on positive data from a small-scale Phase I/II clinical trial (NCT0271611)Received FDA accelerated approval for marketing, isThe first oral therapy targeting EGFR Exon20 insertion mutations.

In July this year, Takeda disclosed in its financial reportExkivityFirst-line treatment for EGFR exon 20（Exon20）Insertion Mutation in NSCLCPhase III EXCLAIM-2 Study Terminated Due to Inefficacy. And thisThe voluntary withdrawal of this indication was also based on the fact that the study did not meet its primary endpoint and did not comply.The confirmatory data requirements for FDA-granted accelerated approval, as well as the requirements for conditional marketing authorization granted by other countries, are not met.Takeda stated that it plans to initiate a voluntary withdrawal worldwide.

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