AstraZeneca and MedImmune, its global biologics research and development arm, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion, recommending a marketing Imfinzi for the treatment of a type of lung cancer.
Sean Bohen, executive vice president, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “The CHMP positive opinion brings European patients closer to having a treatment following chemoradiation therapy. There have been no new treatments in this setting for decades. With approximately a third of European non-small cell lung cancer patients presenting with this stage of disease, we are excited by this potential new standard of care in this curative-intent setting.”
In the PACIFIC trial, Imfinzi demonstrated a statistically-significant and clinically-meaningful improvement in PFS and OS in “all-comer” patients. Overall survival results from the PACIFIC trial will be presented at a forthcoming medical meeting.
The positive opinion from the CHMP will now be reviewed by the European Commission, which has the authority to approve medicines for the 28 European Union member countries plus Iceland, Norway and Liechtenstein.
Earlier this year, Imfinzi was approved in several other nations, including the U.S.
Stage III non small cell lung cancer is estimated to affect around 105,000 patients in the top-eight countries (China, France, Germany, Italy, Japan, Spain, UK, US) in 2017.
No new treatments beyond chemoradiation therapy, followed by active surveillance to monitor for progression, have been available to patients for decades.