AstraZeneca Tagrisso Approved by China CFDA

Tagrisso(omisertinib) is a new lung cancer drug from pharmaceutical giant AstraZeneca, and it is also the first drug approved for T790M mutation-positive NSCLC that has progressed during or after EGFR-TKI treatment. At present, it has been approved for listing in the United States, the European Union and Japan, and was approved by the China Food and Drug Administration (CFDA) at the end of March this year, called Tagrisso (osimertinib mesylate tablets, AZD9291).

The drug belongs to the US patent US7803839 filed in 2006 and has been authorized at present. The corresponding Chinese patent is CN101365676 and is valid until 2025. The once-a-day pill has passed through one of the fastest development plans to date-in just two and a half years from the start of clinical trials to approval.

Late-stage data showing that AstraZeneca's Tagrisso extended the survival of lung cancer patients with specific mutations without worsening the disease may signal a new standard of second-line treatment.

The first randomized phase III clinical trial for Tagrisso and chemotherapy (AURA3) showed that Tagrisso was able to extend the progression-free survival (PFS) of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)T790M positive mutation by 5.7 months. The data showed that the PFS of the two was 10.1 months and 4.4 months respectively.

In addition, AstraZeneca notes that in 34% of patients with the presence of central nervous system (CNS) metastases, the PFS of patients treated with Tagrisso reached 8.5 months compared to 8.5 months with chemotherapy, which is significantly greater than 4.2 months with chemotherapy. Overall, Tagrisso was able to reduce the risk of disease progression by 70% compared to standard platinum-based two-way chemotherapy.

Sean Bohen, Executive Vice President and Chief Medical Officer of Global Drug Development at AstraZeneca, said: "The definitive phase III data indicate that Tagrisso has the potential to replace chemotherapy as the standard of care for patients who have progressed after treatment with an EGFR tyrosine kinase inhibitor."

"Since lung cancer is the most common type of cancer that spreads easily to the brain, it is encouraging to see Tagrisso playing a positive role in patients with CNS metastases, who usually have a particularly poor prognosis."

Dr. Vassiliki A- Papadimitrakopoulou, from the University of Texas MD Anderson Cancer Center, said: "The results of AURA3 are not only statistically significant, but also clinically meaningful because this is the first time that a targeted drug like Tagrisso has shown better improvement in progression-free survival than standard platinum-pemetrexed chemotherapy. This type of news is very beneficial for patients because it highlights the major progress we have made in targeted therapy for lung cancer."

As a result of demonstrating its role in or after TKI treatment of EGFR in FDA-approved trials, Tagrisso received accelerated approval from the FDA in November 2015 for the treatment of NSCLC patients with metastatic EGFR T790M positive mutation.

In addition, Tagrisso is the first drug in the AstraZeneca pipeline to be approved through the CFDA's priority review channel. Sean Bohen said that in China, the EGFR mutation rate is the highest in the world; the CFDA approval Tagrisso will provide AstraZeneca with a huge opportunity to bring a breakthrough treatment for the vast number of lung cancer patients in China.

News source:http://news.bioon.com/article/6701018.html

This news was re-edited and reorganized by the Huaxun team and added analytical comments.