- US FDA approval for liver cancer drug combination
- First approval for dual immunotherapy-based treatment
- Broadens scope across gastrointestinal cancers
Pharma giant AstraZeneca (AZN) said the US FDA (Federal Drug Administration) had approved a combination of its cancer drug Imfinzi with its antibody drug Imjudo to treat patients with HCC (unresectable hepatocellular carcinoma), the most common type of liver cancer.
Approval follows successful results from a phase three HIMALAYA trial where patients treated with the novel immunotherapy-based treatment experienced a 22% reduction in the risk of death compared with chemotherapy.
The FDA gave the application an accelerated evaluation which also included a concurrent review across multiple international regulators as part of the Project Orbis programme.
Project Orbis is a programme to review and approve promising cancer drugs helping patients access treatments faster.
Andrea Wilson Woods of The Adrienne Wilson Liver Cancer Foundation said: ‘These new treatments can improve long-term survival for those living with unresectable hepatocellular carcinoma, the most common form of liver cancer.
‘We appreciate the patients, their families, and the broader liver cancer community who continue to fight for new treatments and advocate for others.’
AstraZeneca shares nudged up 0.1% to £97.29 taking year-to-date gains to 15% compared with a loss of 7% for the FTSE 100.
WHY IT IS IMPORTANT
The approval is the first of its kind for AstraZeneca’s dual immunotherapy-based treatment and broadens the potential scope for Imfinzi to be used in gastrointestinal related cancers.
Healthcare analyst Dr. Susi Jana at Shore Capital reckons only around 15% of fiscal 2026 estimates incorporate pipeline indications outside of lung cancer which provides ‘an important source of incremental growth.’
Jana continues, ‘Imfinzi’s ability to deliver positive data across the breadth of ongoing trials could in our view be an important source of upgrades’.
AstraZeneca said ‘Imfinzi is being tested as a single agent and in combinations with other anti-cancer treatments for patients with several gastrointestinal cancers, ovarian cancer, endometrial cancer, and other solid tumours.’
