Mobocertinib Receives Approval in China for Previously Treated EGFR Exon 20 Insertion–Mutated NSCLC


The National Medical Products Administration of China gives approval to mobocertinib for patients with non–small cell lung cancer harboring EGFR exon 20 insertion mutations.

Mobocertinib (Exkivity; TAK-788) has received approval from the National Medical Products Administration in China for treating adult patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations that has progressed on or after platinum-based chemotherapy, according to a press release from Takeda.1

The approval was supported by data from a phase 1/2 trial (NCT04535557) in which investigators evaluated mobocertinib among 114 patients with platinum-treated, EGFR exon 20 insertion-mutated NSCLC. The agent yielded a confirmed overall response rate of 28% per independent review committee and a median duration of response of 15.8 months. Additionally, there was a median overall survival of 20.2 months and a median progression-free survival of 7.3 months.

The most common treatment-related adverse effects observed in the trial included diarrhea (92%), rash (46%), paronychia (38%), and decreased appetite (37%).

“[Mobocertinib] offers a targeted, oral therapy to a population that has been historically underserved, and this approval brings us one step closer to defeating this complex and heterogeneous disease for patients in [China]” Sean Shan, president of Takeda China, said in the press release.

Previously, mobocertinib was granted approval by the FDA for the treatment of patients with EGFR exon 20 insertion-mutated NSCLC in September 2021.2 The FDA based its approval on findings from the same phase 1/2 trial, the data of which were presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting. In the presentation, trial investigators indicated that mobocertinib produced encouraging responses and a safety profile that was consistent with those reported in other EGFR tyrosine kinase inhibitors.


  1. Takeda’s EXKIVITY® (mobocertinib) receives approval from the NMPA of China, becoming the first and only therapy available for patients with EGFR exon 20 insertion+ NSCLC. News release. Takeda. January 11, 2023. Accessed January 11, 2023.
  2. Takeda’s EXKIVITY™ (mobocertinib) approved by U.S. FDA as the first oral therapy specifically designed for patients with EGFR Exon20 insertion+ NSCLC. News release. Takeda Pharmaceutical Company Limited. September 15, 2021. Accessed January 11, 2023.
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