The London stock market listed company AstraZeneca Monday announced that the China Food and Drug Administration (CFDA) has granted marketing authorization for its lung cancer pill Tagrisso in China.
Tagrisso (osimertinib) is designed for the treatment of adult patients with certain genetic mutations, which is the first AstraZeneca medicine approved under the CFDA's Priority Review pathway, using an accelerated timeline for an innovative medicine.
Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: "This is an important step forward for Tagrisso and a significant opportunity to bring a breakthrough medicine to patients with NSCLC (non-small cell lung cancer) in China, where EGFR (epidermal growth factor receptor) rates are some of the highest in the world."
According to the company, the rapid review and approval signal the urgent need for new, targeted treatments with the potential to address specific types of cancer with high incidence rate and significant unmet medical need in China.
