New Delhi: AstraZeneca Pharma India 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.