AstraZeneca gets Imfinzi approval in China

(Sharecast News) - AstraZeneca announced on Thursday that it has received marketing authorisation from China's National Medical Products Administration (NMPA) for 'Imfinzi' - durvalumab - for the treatment of patients with unresectable, stage 3 non-small cell lung cancer (NSCLC), whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (CRT).
The FTSE 100 pharmaceuticals giant said the approval of Imfinzi was based on results from the primary analysis of progression-free survival, and supported by overall survival from the phase 3 'PACIFIC' trial.

It said a post-hoc analysis of three-year overall survival results had since shown that consistent efficacy was maintained for treatment with Imfinzi after additional follow up.

"This approval illustrates our long-standing commitment to improving health outcomes in China, where more than one-third of the world's lung cancer diagnoses and deaths occur," said Dave Fredrickson, executive vice-president of AstraZeneca's oncology business unit.

"As the global standard of care in this curative-intent setting, Imfinzi is an important new option for patients in China."

The company said the results demonstrated a "statistically significant and clinically meaningful" overall survival and progression-free survival benefit for treatment with Imfinzi, when compared to placebo after concurrent chemotherapy and radiation therapy.

Imfinzi reduced the risk of death by 32%, and prolonged the time patients lived without disease progression or death by more than 11 months.

Among patients treated with Imfinzi, the most common adverse reactions were cough, fatigue, pneumonitis or radiation pneumonitis, upper respiratory tract infections, dyspnoea, and rash.

AstraZeneca said serious adverse reactions occurred in 29% of patients treated with Imfinzi, with 15% of patients discontinuing treatment due to adverse reactions.

Imfinzi is approved in the curative-intent setting of unresectable, stage 3 NSCLC after chemotherapy and radiation therapy in 54 countries and regions, including the United States, Japan and across the European Union, based on the phase 3 PACIFIC trial.

The PACIFIC regimen of chemotherapy and radiation therapy followed by Imfinzi is the global standard of care for the treatment of unresectable stage 3 NSCLC.

At 0844 GMT, shares in AstraZeneca were up 0.01% at 7,307p.