Central Drugs Standard Control Organisation (CDSCO) has approved the import, sell and distribution of durvalumab (Imfinzi) solution for infusion by AstraZeneca Pharma India Ltd.
The approval is for two dosing forms: 120 mg/2.4 ml and 500 mg/10 ml. The new approval brings an added indication to an already approved antibody (also known as immune checkpoint inhibitors).
Durvalumab is now approved for the treatment of patients with limited-stage small cell lung cancer (LS-SCLC). The drug is designed for use in LS-SCLC patients whose disease has not progressed after platinum-based chemoradiation therapy (CRT).
The approval was announced by AstraZeneca Pharma India in a regulatory filing on March 7, 2025. The approval allows AstraZeneca to market and distribute durvalumab in India for this additional indication. The company added that the rollout of durvalumab for this indication is contingent upon any additional regulatory approvals needed.
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