Pharma giant AstraZeneca's (AZN.L) drug to treat lung cancer has won approval in China in the latest win for the drug manufacturer.
Imfinzi (durvalumab) is a drug that treats small cell lung cancer, a highly aggressive, fast-growing form of lung cancer that typically recurs and progresses rapidly despite initial response to chemotherapy.
Prognosis is particularly poor, as only 7% of all SCLC patients and 3% of those with extensive-stage disease will be alive five years after diagnosis.
The approval by China's National Medical Products Administration was based on positive results from the CASPIAN Phase III trial.
The trial showed that Imfinzi plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) versus chemotherapy alone, AstraZeneca said.
In addition, results from the China cohort of patients were consistent with the global results.
AstraZeneca's shares were 1.2% lower in afternoon trade in London — in line with broader declines in the market due to jitters linked to the UK's easing of coronavirus restrictions.
"Today's approval of Imfinzi plus chemotherapy brings an important global standard of care to patients with extensive-stage small cell lung cancer in China, who have had few treatment options and a dire prognosis," said Dave Fredrickson, executive vice president of AstraZeneca's Oncology Business Unit.
"Physicians can now offer these patients a well-tolerated immunotherapy regimen with sustained overall survival and prolonged treatment response, as well as convenient dosing. This is also the first time physicians have had the choice to combine immunotherapy with cisplatin, a preferred chemotherapy in this setting in China."
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