Takeda's new oral small molecule drug mobocertinib capsule is included in priority review in China

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

According to the entry priority review record, the indications for this application for marketing are: treatment of locally advanced or metastatic non-small cell lung cancer ( NSCLC) adult patients

EGFR mutations are common gene mutations in patients with non-small cell lung cancer, accounting for about 10% to 15%.

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

Data from a phase I/II clinical trial (NCT0271611) proved the efficacy and safety of mobocertinib

The safety of Mobocertinib is controllable.

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

Original title: The first insertion mutation therapy for EGFR/HER2 Exon20 was declared for marketing in China and included in priority review