AstraZeneca : EU Approves Imfinzi For Locally-advanced, Unresectable NSCLC

(RTTNews) - AstraZeneca (AZN.L, AZN) and MedImmune, its global biologics research and development arm, announced that the European Commission has granted marketing authorisation for Imfinzi or durvalumab as monotherapy for the treatment of locally-advanced, unresectable non-small cell lung cancer or NSCLC in adults whose tumours express PD-L1 on =1% of tumour cells and whose disease has not progressed following platinum-based chemotherapy and radiation therapy or CRT. The approval is based on results from the Phase III PACIFIC trial.

The approval follows the positive opinion on 27 July 2018 from the CHMP of the European Medicines Agency.

The most common adverse reactions (greater than or equal to 20% of patients) of Imfinzi versus placebo were cough (40.2% vs. 30.3%), upper respiratory tract infections (26.1% vs 11.5%) and rash (21.7% vs 12.0%). 12.8% of patients experienced a grade 3 or 4 AE with Imfinzi vs 9.8% with placebo.

Imfinzi is approved for the treatment of patients with unresectable, Stage III (locally-advanced) NSCLC in the US, Canada, Switzerland, India, Japan and Brazil. Other global health authority reviews and submissions are ongoing.

Stage III (locally-advanced) NSCLC is divided into three sub-categories (IIIA, IIIB and IIIC), defined by how much the cancer has spread locally and the possibility of surgery. Stage III disease is different from Stage IV disease, when the cancer has spread (metastasised) to distant organs, as Stage III is currently treated with curative intent.