Osimertinib(泰瑞沙)是什么时候上市的,Osimertinib(Osimertinib)最早是在2015年11月获得美国食品药品监督管理局（FDA）的加速批准，目前在国内已经上市，国内最早获批的时间是2017年3月，由国家药品监督管理局（NMPA）批准。

Osimertinib, also known by its brand name Tagrisso, is a targeted therapy medication used in the treatment of non-small cell lung cancer (NSCLC). It is specifically approved for patients with NSCLC that has a specific mutation called EGFR T790M, which makes the cancer resistant to other EGFR inhibitors. Osimertinib has been proven effective in improving progression-free survival in these patients. It is important to note that this article reflects information up until September 2021, and any updates on the market availability of Osimertinib should be verified with recent sources.

1. Introduction:

Osimertinib has emerged as a breakthrough treatment option for patients with advanced NSCLC harboring the EGFR T790M mutation. With its unique mechanism of action, this targeted therapy has shown promising results in clinical trials, leading to its approval for commercial use. In this article, we will explore when Osimertinib was first introduced to the market and its significance in the treatment of lung cancer.

2. Development and Clinical Trials:

The development of Osimertinib began in the early 2000s when researchers recognized the need for more effective treatments for NSCLC patients with EGFR mutations. Preclinical studies and early-phase clinical trials demonstrated Osimertinib's potential to inhibit cancer growth while sparing normal cells. These promising results paved the way for further clinical investigation.

Subsequent clinical trials, such as the AURA trial, assessed the safety and efficacy of Osimertinib in patients with EGFR T790M-positive advanced NSCLC. The trial outcomes demonstrated significant improvements in objective response rates and progression-free survival compared to traditional chemotherapy and other EGFR inhibitors.

3. Regulatory Approval and Market Introduction:

The positive results from clinical trials led to a fast-track designation and accelerated approval process for Osimertinib by regulatory authorities worldwide. In November 2015, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Osimertinib for the treatment of patients with EGFR T790M-positive metastatic NSCLC who have progressed on or after EGFR TKI therapy.

Since then, Osimertinib has received additional regulatory approvals in various countries, including the European Union, Japan, China, and many others. These approvals allowed for the wider availability of Osimertinib, making it accessible to more patients in need.

4. Impact on Lung Cancer Treatment:

The introduction of Osimertinib to the market has brought about a significant shift in the treatment landscape for advanced NSCLC patients with the EGFR T790M mutation. Prior to Osimertinib's approval, the options for these patients were limited, often relying on chemotherapy or less effective EGFR inhibitors.

Osimertinib's targeted mechanism of action and improved efficacy have demonstrated superior outcomes in terms of both disease control and patient quality of life. With its ability to cross the blood-brain barrier, Osimertinib has also shown efficacy against brain metastases, which are common in patients with NSCLC.

In conclusion, Osimertinib was first introduced to the market in November 2015 after receiving accelerated approval by the FDA for the treatment of EGFR T790M-positive metastatic NSCLC. Since then, it has become a crucial therapeutic option for patients with this specific mutation, significantly improving outcomes and transforming the treatment landscape for advanced NSCLC patients. As research and development continue, the role of Osimertinib in lung cancer treatment is expected to evolve, providing even more benefits for patients in the future.