AstraZeneca India secures CDSCO approval for Durvalumab in advanced liver cancer

The therapy can now be used to treat patients with unresectable hepatocellular carcinoma (uHCC) who have not previously received systemic treatment.

Hepatocellular carcinoma (HCC) remains a major global health challenge, ranking as the sixth most common cancer and the third leading cause of cancer-related deaths worldwide.

In India, data from GLOBOCAN 2022 indicates that over 38,000 new HCC cases are diagnosed each year, making it the country’s 11th most common cancer. Due to its high mortality rate, it is also the eighth leading cause of cancer deaths, highlighting the need for more effective therapies.

The approval is supported by findings from the Phase III HIMALAYA trial, which evaluated durvalumab both as a monotherapy and in combination with tremelimumab under the STRIDE regimen.

The combination approach demonstrated improved outcomes compared to sorafenib, while durvalumab alone showed non-inferior overall survival along with a favourable benefit-risk profile, particularly for patients who are not eligible for other treatment options such as immunotherapy combinations or anti-VEGF therapies.

According to Praveen Rao Akkinepally, Country President and Managing Director of AstraZeneca Pharma India, the approval marks an important step in expanding treatment options for patients with advanced liver cancer.

He noted that many patients are diagnosed at later stages and face limited therapeutic choices, making access to effective and well-tolerated treatments critical.

The approved regimen involves administering a fixed dose of durvalumab (1500 mg) every four weeks until disease progression or unacceptable toxicity.

The therapy is expected to provide a new option for patients with unresectable HCC, particularly those unable to undergo other standard treatments.

AstraZeneca said the approval reinforces its commitment to improving patient outcomes and expanding access to innovative cancer therapies across India.