Takeda’s Exkivity (mobocertinib) Receives the US FDA’s Approval as the First Oral Therapy for EGFR Exon20 Insertion+ NSCLC

September 16, 2021 Auto Bot approval, FDA, Takeda, Uncategorized 0

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

Click here to­ read full press release/ article | Ref: Business Wire | Image: Reuters

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