AstraZeneca announced that it received the registration certificate in Russia for Tagrisso® (osimertinib), a drug for the treatment of locally-advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small-cell lung cancer (NSCLC).
The drug was approved following AURA3 randomized Phase III clinical trials.
Olga Somina, the Director of Oncology at AstraZeneca said, “Osimertinib is the first and only drug approved in Russia for the treatment of patients diagnosed with T790M mutation-positive non-small-cell lung cancer. The clinical trial data on the efficacy of osimertinib suggest that this drug may become the new standard of targeted therapy for lung cancer. As a company that developed gefitinib, a first-generation tyrosine kinase inhibitor, we continue to invest in R&D, clinical trials and manufacturing of highly effective drugs to fight this life threatening disease.”
In September 2017, AstraZeneca launched the technology transfer process for manufacturing osimertinib. The drug will be manufactured at the company plant in Vorsino Industrial Park (Kaluga region).