AstraZeneca’s Durvalumab Receives Go-Ahead from DCGI to Market in India

June 26, 2018  Source: United News of India 2,015

Last Friday, pharma giant AstraZeneca announced that it had received the go-ahead from the Drug Controller General of India (DCGI) to import and market durvalumab (ImfinziTM) in India. The receipt of this permission paves the way for the launch of durvalumab (ImfinziTM) in India. Durvalumab which is a patented drug of AstraZeneca, received permission in India to provide treatment for patients with unresectable non-small cell lung cancer and metastatic urothelial carcinoma.

Some forms of lung and bladder cancer use the protein PD-L1 to escape the immune system, durvalumab is a human monoclonal antibody that ties PD-L1 and obstructs the interaction of PD-L1 with PD-1 and CD80, tackling the tumor's immune-evading tactics and spreading the inhibition of immune responses. A new immunotherapy drug durvalumab by AstraZeneca is known as checkpoint inhibitors.’

“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 tremendous breakthrough for patients who have currently few treatment options. In India, approximately one-3rd of patients with NSCLC are suffering from Stage III disease and we are excited to bring the first immunotherapy into this setting for patients,” said Gagan Singh, Managing Director, AstraZeneca Pharma India Limited.

By Ddu