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FDA Grants Mobocertinib Breakthrough Designation for EGFR Exon 20–Mutant NSCLC

Jason M. Broderick @jasoncology
Published: Monday, Apr 27, 2020

The FDA has granted a breakthrough therapy designation to mobocertinib (TAK-788) for the treatment of patients with EGFR exon 20–mutant non–small cell lung cancer (NSCLC) with disease progression following platinum-based chemotherapy, according to Takeda Pharmaceutical Company Limited, the manufacturer of the small-molecule TKI.1 

-dependent resistance. Six of 20 patients who had exon 20 insertions had best timepoint response of PR, with 3 confirmed.


  1. Takeda Announces U.S. FDA Breakthrough Therapy Designation for Mobocertinib (TAK-788) for the Treatment of NSCLC Patients with EGFR Exon 20 Insertion Mutations Published April 27, 2020.  Accessed April 27, 2020.
  2. Haura EB, Cho BC, Lee JS, et al. JNJ-61186372 (JNJ-372), an EGFR-cMet bispecific antibody, in EGFR-driven advanced non-small cell lung cancer (NSCLC). J Clin Oncol. 2019;37(suppl 15; abstr 9009). doi: 10.1200/JCO.2019.37.15_suppl.9009

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