AstraZeneca has announced that its drug Imfinzi has been recommended for approval in the European Union by the Committee for Medicinal Products for Human Use (CHMP) as the first and currently only immunotherapy for limited-stage small cell lung cancer. This endorsement by the European Medicines Agency committee follows promising results from the ADRIATIC Phase III trial. AstraZeneca highlighted that Imfinzi's safety profile remains generally manageable and aligns with its established characteristics.
In addition to the EU, Imfinzi is already approved for use in the United States and several other countries for the same condition. Regulatory reviews of Imfinzi applications are also ongoing in Japan and multiple other nations for this particular treatment indication.
