Key Highlights:
- AstraZeneca Pharma India received approval from Central Drugs Standard Control Organisation for an additional indication of Durvalumab to treat unresectable hepatocellular carcinoma (uHCC) in patients with no prior systemic therapy.
- The approval is backed by the Phase III HIMALAYA trial, where Durvalumab (± tremelimumab, STRIDE regimen) showed superior or non-inferior survival vs. sorafenib, offering a favorable benefit-risk profile, especially for the 25–30% patients ineligible for existing therapies.
- With ~38,000 new HCC cases annually in India and high mortality, this approval introduces a once-every-4-week immunotherapy option, addressing a critical unmet need and expanding access to effective treatment for advanced liver cancer.
Implications:
The new indication firmly positions durvalumab as a frontline immunotherapy option in advanced liver cancer, giving oncologists a more convenient, once‑every‑4‑week regimen for patients who previously had limited systemic choices.
By offering a non-inferior or superior alternative to sorafenib with a favorable benefit‑risk profile, AstraZeneca strengthens its oncology franchise in India and is likely to drive greater adoption of IO-based treatment algorithms in uHCC.
Given the high mortality and late-stage diagnosis of HCC in India, the approval can also catalyze more referrals to tertiary centers and encourage payers and institutions to re-evaluate reimbursement and access pathways for liver cancer immunotherapy.
Source: Express Pharma | Image: AstraZeneca
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