Controller General of India approved AstraZeneca’s Imfinzi (durvalumab) for the treatment of unresectable non-small cell lung cancer (NSCLC).
Several checkpoint inhibitors, a type of immunotherapy for the treatment of cancer, have been approved in the US, but these advanced therapies are only now becoming available to patients in emerging markets. Earlier in June, the China Drug Administration approved the first PD-1/L1 checkpoint inhibitor [Bristol-Myers’ Opdivo (nivolumab)] for the 2nd line treatment of patients with locally advanced or metastatic NSCLC.
Now India’s drug agency has taken a similar step, but this time it is AstraZeneca’s PD-1/L1 checkpoint inhibitor Imfinzi (durvalumab) that received the nod for the treatment of patients with unresectable non-small cell lung cancer (NSCLC). The approval from the Drug Controller General of India (DCGI) follows an approval from the US FDA in February 2018.
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,” said Gagan Singh, Managing Director at AstraZeneca Pharma India.