AstraZeneca Pharma India has received an import & market permission for durvalumab (Imfinzi) from the Drug Controller General of India (DCGI). The receipt of this permission paves way for the launch of durvalumab under the brand name Imfinzi in India, subject to the receipt of further related statutory approvals and licenses.

Durvalumab is a patented product of AstraZeneca global and is a treatment option for patient with locally advanced, unresectable non-small cell lung cancer (NSCLC) and metastatic urothelial carcinoma.

“The import and market permission for durvalumab for unresectable stage III non-small cell lung cancer 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,” stated Gagan Singh, managing director, AstraZeneca Pharma India.

Durvalumab is a part of a new class of immunotherapy drugs of the company 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.

NSCLC accounts for about 85 per cent of all lung cancers. In general, lung cancer is the most common cancer in Indian men and accounts for most number of deaths (13.7 per cent) from cancer. Incidence of Stage III NSCLC in one study in India was found to be 28.7 per cent, representing approximately one-third of NSCLC incidence.

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.