AstraZeneca clears US regulatory hurdle for new cancer drug Imfinzi


harma giant AstraZeneca has cleared US regulatory hurdles to begin using its Imfinzi drug for the treatment of patients with gallbladder and bile duct cancer in a breakthrough for people with a rare but aggressive form of the disease.

Approval by the Food and Drug Administration follows final stage trials of the drug which showed it could reduce the risk of death by 20% compared with chemotherapy alone. Imfinzi is already approved in the US for treatment of lung cancer.

Aiwu Ruth He, associate professor of medicine at Medstar Georgetown University Hospital, Washington DC, said: “This approval represents a major step forward for patients with advanced biliary tract cancer, who urgently need new, well-tolerated and effective treatment options after more than a decade of limited innovation.”

Over 1,000 people are diagnosed with gallbladder cancer in the UK each year, according to Cancer Research, with only 5%-15% of patients surviving five years, AstraZeneca said.

Astra also announced the approval of its kidney disease treatment by health regulators in China. The drug, called Farxiga, was shown to cut the risk of cardiovascular and renal death by 39% after a successful phase-three trial.

The Cambridge-based company first developed the drug as a treatment for type-2 diabetes in partnership with US company Bristol Myers Squibb. It was approved for medical use by the EU drugs regulator in 2012.

Last week, the pharma giant said it found Farxiga had significantly lowered death in patients who have already suffered heart failure, a major cause of death in the UK.

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