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|Articles|July 20, 2021
AstraZeneca’s Extensive-Stage Small Cell Lung Cancer Treatment Approved in China
Author(s)BioPharm International Editors
In combination with etoposide and either carboplatin or cisplatin, Imfinzi has been approved in the first-line setting of ES-SCLC by China’s National Medical Products Administration.
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According to a July 19, 2021 press release, AstraZeneca’s Imfinzi (durvalumab) has been approved by China’s National Medical Products Administration for the first-line treatment of adult patients in China with extensive-stage small cell lung cancer (ES-SCLC) in combination with standard of care platinum chemotherapy (etoposide plus a choice of either carboplatin or cisplatin).
SCLC is a type of lung cancer that is aggressive and fast-growing. Typically, it recurs and progresses rapidly despite any initial response to chemotherapy. Approximately, seven percent of all SCLC patients and three percent of those with ES-SCLC will survive five years after diagnosis.
The CASPIAN Phase III trial found that Imfinzi plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) as compared to chemotherapy alone. In June 2019, the CASPIAN Phase III trial met the primary endpoint of OS for Imfinzi plus chemotherapy. The risk of death was reduced by 27% versus chemotherapy alone, with a median OS of 13.0 months versus 10.3 months for chemotherapy alone. These results were published in The Lancet in October 2019. In addition, results from the China cohort of patients were consistent with the global results.
In the trial, a fixed dose of Imfinzi (1500 mg) was administered every three weeks for four cycles in combination with chemotherapy and then every four weeks as a monotherapy until disease progression. Based on the results, Imfinzi, in combination with etoposide and either carboplatin or cisplatin, has been approved in the first-line setting of ES-SCLC in more than 55 countries, including the US, Japan, and across the EU.
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