AstraZeneca Pharma India today said it has received approval from the Indian drug regulator to market Durvalumab, a cancer treatment medicine, in the country.
The company has received import and market permission for Durvalumab from the Drug Controller General of India (DCGI), AstraZeneca Pharma India said in a statement.
The approval paves the way for the company to launch the product in the country, it added.
Durvalumab is indicated as a treatment option for patients 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 (NSCLC) and locally advanced or metastatic urothelial carcinoma is a significant milestone for patients who have currently limited treatment options," AstraZeneca Pharma India Managing Director Gagan Singh said.
In India, around one third of patients with NSCLC are present with stage III disease and the company is happy to bring the first immunotherapy into this setting for patients, he added.