Teresa's first-line treatment of NSLCL indications will be approved by medical insurance and will be approved for postoperative adjuvant treatment of lung cancer

Text | Dopine

Recently, AstraZeneca's osimertinib mesylate tablets (trade name: Teresa) has entered the administrative examination and approval stage for category 2.

Osimertinib mesylate (osimertinib; Tagrisso) is a third representative skin growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), approved by the FDA in 2015 for the treatment of treated NSCLC, 2018 It was approved by the FDA for the first-line treatment of metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R mutation in December 2020.

According to the latest global cancer burden data released by the International Agency for Research on Cancer (IARC) of the World Health Organization in 2020, lung cancer ranks second in global incidence and first in mortality, of which approximately 80%-85% belong to NSCLC.

How to reduce the risk of recurrence of lung cancer patients after surgery and improve the quality of life of patients has always been the goal of clinical research.

Since it was approved for marketing in 2015, osimertinib has developed from a second-line drug for advanced NSCLC to a first-line drug, and from a late-stage NSCLC drug to an early-stage drug, reshaping the EGFR drug system.

In China, osimertinib was first approved by the NMPA in March 2017 for use in adult patients with locally advanced or metastatic NSCLC who have experienced disease progression during or after treatment with EGFR-TKIs, and have been tested to confirm the presence of EGFR T790M mutation-positive adult patients with locally advanced or metastatic NSCLC , The product name is Teresa, and it was included in the national medical insurance in 2018.

It is hoped that osimertinib can be officially approved in China as soon as possible for the adjuvant treatment of EGFR-mutant NSCLC adult patients after surgery.

Three generations of EGFR-TKIs in the domestic market stand out, and two more have been reported for production

At present, three types of EGFR-TKIs have been approved in China, namely Osimertinib, Ametinib and Iflutinib, two of which are domestically produced and one is imported.

In addition, there are currently two third-generation EGFR-TKIs in the marketing application stage, namely Avitinib from Aisen Biotech and Befortinib from Betta Pharmaceuticals.

From the third-generation EGFR-TKIs market alone, it can be seen that my country's pharmaceutical industry has continued to strengthen its research and development capabilities, and my country's pharmaceutical industry has begun to gradually enter overseas markets.

In addition, in addition to Ametinib and Vometinib, there is also a domestically-made EGFR-TKI among the many EGFR-TKIs approved in China, namely Icotinib of Betta Pharmaceuticals (trade name: Kemena).