Introduction to relevant information on Dacomitinib (Dacomitinib) Tablets obtaining the drug registration certificate

Dacomitinib tablets are an oral, irreversible second-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) developed and produced by Pfizer. The drug was approved by the U.S. Food and Drug Administration (FDA) in September 2018 for the treatment of patients with EGFRexons First-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with span>19 deletion or 21 exonL858R substitution mutation.

In mainland China, dacomitinib tablets are produced by Pfizer Pharmaceuticals Ltd. (Pfizer Pharmaceuticals Ltd.). According to the announcement from the National Medical Products Administration (NMPA), dacomitinib tablets were released on 20195, it obtained the drug registration certificate from the State Food and Drug Administration of China. The registration number is J20180038. The approval makes dacomitinib a first-line treatment option available in the Chinese market for patients with EGFR mutation-positive non-small cell lung cancer.

The registration approval of dacomitinib is based on data from multiple clinical studies, especiallyARCHER 1050Study, this study shows that dacomitinib can significantly prolong progression-free survival (PFS) and overall survival (OS) compared with gefitinib in patients with EGFR mutation-positive non-small cell lung cancer. The recommended dose of this drug is 45 mg once daily with or without food. Common adverse reactions include diarrhea, rash, paronychia, and oral mucositis.

In short, the drug registration certificate for dacomitinib tablets was issued by the China State Food and Drug Administration, and the registration number isJ20180038, the manufacturer is Pfizer Pharmaceutical Co., Ltd. The approval of this drug provides a new treatment option for patients with EGFR mutation-positive non-small cell lung cancer in China and fills a gap in the market.

Reference materials:https://www.drugs.com