Drug firm AstraZeneca Pharma India Ltd on Friday (March 7) said it has received approval from the Central Drugs Standard Control Organisation (CDSCO) to import, sell, and distribute durvalumab (Imfinzi) solution for infusion in 120 mg/2.4 ml and 500 mg/10 ml doses for an additional indication.
“This is to inform that AstraZeneca Pharma India Limited has received permission from the Central Drugs Standard Control Organisation, Directorate General of Health Services, Government of India to import for sale and distribution of Durvalumab solution for infusion 120 mg/2.4 ml and 500 mg/10 ml (Imfinzi) for an additional indication,” AstraZeneca Pharma said in a regulatory filing.
With this approval, durvalumab can now be used for treating patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy (CRT).
“Through this approval, Durvalumab is indicated for the treatment of patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy (CRT),” it said.
The regulatory clearance allows AstraZeneca to move forward with the marketing of durvalumab in India for this new indication, subject to any further statutory approvals.
“The receipt of this permission paves the way for the marketing of Durvalumab solution for infusion 120 mg/2.4 ml and 500 mg/10 ml (Imfinzi) in India for the specified additional indication, subject to the receipt of related statutory approvals, if any,” AstraZeneca Pharma added.