AstraZeneca Pharma India Ltd has received approval from the Central Drugs Standard Control Organisation (CDSCO) to import and market Durvalumab (Imfinzi) solutions in India. This permission paves the way for its use in treating non-small cell lung cancer (NSCLC) and unresectable hepatocellular carcinoma, strengthening India’s oncology treatment options.
AstraZeneca Pharma India Ltd announced that it has received regulatory clearance from the CDSCO to import and distribute Durvalumab (Imfinzi) solutions in India. The approval covers Durvalumab in both 120 mg/2.4 mL and 500 mg/10 mL infusion formats, enabling its marketing for advanced cancer therapies.
Durvalumab, an immunotherapy drug, is indicated for use in combination with chemotherapy as a neoadjuvant treatment for resectable NSCLC, followed by monotherapy post-surgery. Additionally, it has been approved in combination with Tremelimumab for the treatment of unresectable hepatocellular carcinoma (HCC).
This development marks a significant step in expanding access to cutting-edge cancer treatments in India, aligning with AstraZeneca’s global oncology strategy.
Key Highlights
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Regulatory Approval: CDSCO permits import and sale of Durvalumab solutions.
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Drug Formats: 120 mg/2.4 mL and 500 mg/10 mL infusion solutions.
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Indications: NSCLC (lung cancer) and unresectable HCC (liver cancer).
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Therapy Approach: Combination with chemotherapy or Tremelimumab.
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Market Impact: Strengthens India’s oncology treatment portfolio.
This approval enhances India’s access to advanced immunotherapy, offering new hope for patients battling complex cancers.
Sources: CDSCO Approval Notice, The Economic Times, Business Standard, Capital Market News