Based on positive results in a phase III trial, Imfinzi demonstrated improvement over chemotherapy alone, the approval was granted
AstraZeneca PLC, LON:AZN announced that Imfinzi was approved in China as a first-line treatment for adult patients with advanced-stage small-cell lung cancer (ES-SCLC).
It can be used together with standard of care platinum chemotherapy.
Positive results from a phase 3 trial that showed a statistically significant improvement in overall survival over chemotherapy alone were the basis for approval. The results of the China cohort of patients were also consistent with the global results.
According to FTSE 100, SCLC is a very aggressive and fast-growing type of lung cancer. It can recur and progress quickly despite initial treatment.
The prognosis for SCLC patients is poor. Only 7% and 3% of SCLC patients will live five years after diagnosis.
Dave Fredrickson (executive vice president, oncology business unit) stated that today’s approval for Imfinzi plus chemotherapy provides a global standard of care for patients suffering from advanced-stage small cell lung carcinoma in China. These patients have had limited treatment options and a grim prognosis.
“Physicians are now able to offer these patients an effective immunotherapy regimen that is well-tolerated and has a sustained overall survival rate, prolonged treatment response, and convenient dosing. Physicians will also be able to mix immunotherapy with cisplatin for the first time in China.
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