AstraZeneca Pharma India receives CDSCO approval for Durvalumab for patients with uHCC

AstraZeneca Pharma India, a global, science-led biopharmaceutical company, announced that Central Drugs Standard Control Organisation (CDSCO) has approved an additional indication for Durvalumab solution for infusion (120 mg/2.4 mL and 500 mg/10 mL), for the treatment of patients with unresectable hepatocellular carcinoma (uHCC),who have not received prior systemic therapy.

In India, according to GLOBOCAN 2022, more than 38,000 new cases of HCC are diagnosed annually, making it the 11th most common cancer. HCC’s high mortality rate makes it the 8th leading cause of cancer-related deaths in the country, underscoring the urgent need for effective treatment options.

Durvalumab in combination with single dose of tremelimumab (STRIDE) has been approved in patients with uHCC based on the HIMALAYA global Phase III trial, where the STRIDE regimen showed superior outcomes over sorafenib. While immunotherapy combinations and anti‑VEGF tyrosine kinase inhibitors are available for unresectable HCC, an estimated 25–30% of patients are not eligible for these therapies. In HIMALAYA, durvalumab monotherapy demonstrated non‑inferior overall survival versus sorafenib and demonstrated a favourable benefit risk profile for these patient groups with unresectable HCC.

Praveen Rao Akkinepally, Country President and Managing Director, AstraZeneca Pharma India Limited 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.”

The approved regimen, known as the durvalumab monotherapy regimen, comprises of fixed dose of single agent Durvalumab, an anti-PDL-1 immunotherapy agent 1500 mg given every four weeks until disease progression or unacceptable toxicity.

The CDSCO decision is supported by results from the HIMALAYA Phase III trial, in which durvalumab monotherapy achieved non‑inferior overall survival versus sorafenib with a favourable benefit risk profile in patients with unresectable HCC who had not received prior systemic therapy and were not eligible for locoregional treatment.