AstraZeneca PLC (LON:AZN) announced that Imfinzi has been approved in China for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).
It will be used in combination with standard of care platinum chemotherapy.
READ: AstraZeneca and FibroGen face FDA rejection of anaemia drug
The approval was based on positive results from a phase III trial, where the candidate demonstrated a statistically significant and clinically meaningful improvement in overall survival versus chemotherapy alone. In addition, results from the China cohort of patients were consistent with the global results.
The FTSE 100 firm said that SCLC is 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.
"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 at the 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."