China's National Medical Products Administration has approved AstraZeneca Plc.'s (AZN,AZN.L) Imfinzi or durvalumab for the 1st-line treatment of adult patients with extensive-stage small cell lung cancer or ES-SCLC, in combination with standard of care platinum chemotherapy--etoposide plus a choice of either carboplatin or cisplatin.
The approval 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 versus chemotherapy alone.
Small cell lung cancer 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.
In addition to approvals in ES-SCLC and unresectable, Stage III NSCLC, Imfinzi is approved for previously treated patients with advanced bladder cancer in several countries. Since the first approval in May 2017, more than 100,000 patients have been treated with Imfinzi.
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