AstraZeneca Immunotherapy Drug Earns FDA Approval

AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the FDA has approved Imfinzi for the treatment of certain patients with non-small cell lung cancer (NSCLC), specifically those with unresectable Stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.

Stage III (locally advanced) NSCLC is commonly divided into three sub-categories (IIIA, IIIB and IIIC), defined by how much the cancer has spread locally and the possibility of surgery. This differentiates it from Stage IV disease, when the cancer has spread (metastasised) to distant organs.

Stage III NSCLC represents approximately one-third of NSCLC incidence and was estimated to affect around 105,000 patients in France, Germany, Italy, Japan, Spain, the UK and the US in 2016. The majority of Stage III NSCLC patients are diagnosed with unresectable tumours. Until now, the current standard of care has been chemotherapy and radiation therapy, followed by active surveillance to monitor for progression. The prognosis remains poor and long-term survival rates are low.

Immuno-Oncology (IO) is a therapeutic approach designed to stimulate the body’s immune system to attack tumors. At AstraZeneca and MedImmune, the IO portfolio is anchored by immunotherapies like Imfinzi that have been designed to overcome anti-tumor immune suppression. We believe that IO-based therapies will offer the potential for life-changing cancer treatments for the clear majority of patients. (Source: AstraZeneca Website, 19 February, 2018)