AstraZeneca Pharma India has received approval from the Central Drugs Standard Control Organisation (CDSCO) for an additional indication of durvalumab infusion to treat patients with unresectable hepatocellular carcinoma (uHCC) who have not received prior systemic therapy.

Hepatocellular carcinoma remains a significant health burden in India, with over 38,000 new cases reported annually, according to GLOBOCAN 2022. It is the 11th most common cancer and the eighth leading cause of cancer-related deaths in the country, highlighting the urgent need for effective treatment options.

The approval is supported by results from the global phase-III HIMALAYA trial. In the study, the STRIDE regimen (durvalumab plus a single dose of tremelimumab) demonstrated superior outcomes compared to sorafenib. Additionally, durvalumab monotherapy showed non-inferior Overall Survival (OS) with a favourable benefit-risk profile, particularly for patients ineligible for other treatment options such as immunotherapy combinations or anti-VEGF therapies.

The approved regimen involves a fixed dose of durvalumab (1500 mg) administered every four weeks until disease progression or unacceptable toxicity. This offers a new treatment avenue for patients with limited therapeutic options.

Praveen Rao Akkinepally, Country President and Managing Director, AstraZeneca Pharma India, said, “The durvalumab monotherapy approval offers a new treatment option and brings renewed hope for long-term survivorship with immunotherapy for patients with unresectable hepatocellular carcinoma (uHCC) who have not received prior systemic therapy. However, the unmet need remains significant, too many patients are diagnosed late, face limited options and require treatments that can extend life with good quality. At AstraZeneca, our purpose is to transform patient outcomes and leave no patient behind. This approval advances that ambition by bringing proven science to all patients sooner. Our commitment is to accelerate access responsibly, partner across the health system to reduce barriers, and improve both the length and quality of life for all patients.”