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AstraZeneca receives marketing permission for Durvalumab in India

22 June 2018 | News

Durvalumab is the only immunotherapy approved for patients with unresectable Stage III Non-Small Cell Lung Cancer (NSCLC).



AstraZeneca Pharma India Limited recently announced that it has received Import & Market permission for Durvalumab (Imfinzi) in India by the Drug Controller General of India (DCGI). 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, Managing Director, AstraZeneca Pharma India Limited 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.


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