AstraZeneca receives DCG(I) nod for Durvalumab in India

AstraZeneca Pharma India Limited (AZPIL) has received Import & Market permission for Durvalumab (ImfinziTM) in India by the Drug Controller General India, DCG(I). The receipt of this permission paves way for the launch of durvalumab (ImfinziTM) in India, subject to the receipt of further related statutory approvals and licenses.

Durvalumab provides a treatment option for patient with locally advanced, unresectable Non-Small Cell Lung Cancer (NSCLC) and metastatic urothelial carcinoma. Durvalumab is a patented product of AstraZeneca global.

Gagan Singh, MD, AstraZeneca Pharma India said, "The import and market permission for Durvalumab for unresectable stage III Non-Small Cell Lung Cancer (NSCLC) and locally advanced or metastatic urothelial carcinoma is a significant milestone for patients who have currently limited treatment options. In India, approximately one third of patients with NSCLC are present with Stage III disease and we are excited to bring the first immunotherapy into this setting for patients."

AstraZeneca’s Durvalumab is a part of a new class of immunotherapy drugs known as ‘checkpoint inhibitors’. Some forms of bladder and lung cancer use the PD-L1 protein to evade the immune system. Durvalumab, is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.