AstraZeneca Pharma India Limited has received approval from the Central Drugs Standard Control Organisation (CDSCO), India, to import, sell, and distribute Durvalumab (Imfinzi) solution for infusion in 120 mg/2.4 ml and 500 mg/10 ml formulations for an additional indication.
With this approval, Durvalumab (Imfinzi) is now indicated for the treatment of limited-stage small cell lung cancer (LS-SCLC) in patients whose disease has not progressed after platinum-based chemoradiation therapy (CRT). This expansion strengthens AstraZeneca’s commitment to providing innovative treatments for lung cancer patients in India.
Durvalumab, an immune checkpoint inhibitor, works by enhancing the body’s immune response against cancer cells. Its expanded indication offers new hope for LS-SCLC patients, improving survival outcomes and treatment options.
This approval marks a significant milestone in the availability of advanced oncology therapies in India. AstraZeneca can now market Durvalumab (Imfinzi) for this additional indication, subject to further statutory clearances.
