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The first insertion mutation therapy targeting EGFR/HER2 Exon20 was declared and listed in China and included in the priority review at the same time

 Last Update: 2021-08-09
 Source: Internet
 Author: User

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On July 12, the CDE official website announced that Takeda's new oral small molecule drug mobocertinib capsule has been officially accepted by the State Food and Drug Administration
.

It is the first domestic application for the treatment of EGFR exon 20 (Exon20) insertion mutation NSCLC therapy.

Mobocertinib is a next-generation small molecule tyrosine kinase inhibitor (TKI), specifically designed to selectively inhibit epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor-2 (HER2) exon 20 mutations
.

It was awarded a breakthrough therapy designation by the FDA in April 2020 for the treatment of patients with EGFR Exon20 insertion mutation NSCLC who had disease progression during or after platinum-containing chemotherapy

According to the Medical Rubik's Cube database, among the drugs under development in China that target EGFR Exon20, except for Takeda's mobocertinib, which has been declared for marketing, Dizhe Pharmaceutical DZD9008 is in the phase II clinical stage
.

Zai Lab's CLN-081 and Junjing Bio's AP-L1898 have been approved for clinical use

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