Lung cancer is the leading cause of cancer death and 80%-85% of patients with lung cancer have NSCLC.
This new dosing option is consistent with the approved Imfinzi dosing in extensive-stage small cell lung cancer and is available to patients with locally advanced, unresectable NSCLC weighing more than 30 kilos.
Eligible patients will be adults whose tumours express a protein called PD-L1 on at least 1% of tumour cells and whose disease has not progressed following platinum-based chemoradiation therapy.
The approval follows an accelerated assessment by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, which recommended approval last month. This CHMP recommendation and approval also apply to the UK.
"Less-frequent dosing is important for cancer patients, and may be particularly relevant right now for those suffering from lung cancer, who are especially vulnerable to complications from COVID-19,” said Luis Paz-Ares, chair of the Medical Oncology Department at the Hospital Universitario Doce de Octubre, in Madrid, who was the principal investigator of clinical trials.
“Patients with cancer should be able to focus on living their lives as much as possible and doctors can now offer them a more convenient dosing option that could reduce medical visits by half and help avoid unnecessary risk of exposure to infection in the healthcare setting."