Shots:

• The approval is based on the P-I/II trial evaluating Exkivity (160 mg) in 114 patients with EGFR Exon20 insertion+ NSCLC who received prior Pt-based therapy
• The results demonstrated ORR (28%) as assessed by IRC & 35% as per investigator- m-DoR (17.5mos.)- m-OS (24mos.)- and m-PFS (7.3mos.) as per IRC
• Exkivity is a TKI inhibitor designed to selectively target EGFR Exon20 insertion mutation & has received PR- BTD- FTD & ODD from the FDA. Additionally- the US FDA has approved Thermo Fisher’s Oncomine Dx Target test as an NGS CDx for Exkivity to identify NSCLC patients with EGFR Exon20 insertions

Ref: Business Wire | Image:Takeda