News
Imfinzi recommended for approval by CHMP for less-frequent, fixed-dose use in unresectable non-small cell lung cancer.- AstraZeneca
AstraZeneca's Imfinzi (durvalumab) has been recommended for marketing authorisation in the European Union (EU) for an additional dosing option, 1,500mg fixed dose every four weeks, in the approved indication of locally advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on at least 1% of tumour cells and whose disease has not progressed following platinum-based chemoradiation therapy (CRT).
This new dosing option is consistent with the approved Imfinzi dosing in extensive-stage small cell lung cancer (ES-SCLC) and once approved, will be available to patients with locally advanced, unresectable NSCLC weighing more than 30kg.
Following review of the application under its accelerated assessment procedure, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on data from several Imfinzi clinical trials, including the PACIFIC Phase III trial which supported the two-week, weight-based dosing of 10mg/kg every two weeks already approved in locally advanced, unresectable NSCLC, and the CASPIAN Phase III trial which used fixed dosing every four weeks during maintenance treatment in ES-SCLC.
Condition: Non Small Cell Lung Cancer
Type: drug