The US Food and Drug Administration (FDA) has granted Priority Review for Imfinzi (durvalumab) for the treatment of patients with previously untreated extensive-stage small-cell lung cancer.
Small-cell lung cancer is an aggressive, fast-growing form of lung cancer that recurs and progresses rapidly despite initial response to platinum-based chemotherapy. A Prescription Drug User Fee Act date is set for the first quarter of 2020.
The FDA status was based on positive results from the Phase III CASPIAN trial showing Imfinzi in combination with standard-of-care chemotherapy demonstrated a statistically significant and clinically meaningful improvement in overall survival versus standard of care.
The risk of death was reduced by 27 percent with median survival 13 months for Imfinziplus chemotherapy vs. 10.3 months for standard of care. Results showed an estimated 33.9 percent of patients were alive at 18 months following treatment with Imfinzi plus chemotherapy vs. 24.7 percent of patients receiving standard of care.
Imfinzi is approved for unresectable, Stage III non-small cell lung cancer (NSCLC) after chemoradiation therapy in 54 countries, including the US, Japan and the EU, based on an earlier trial.
Lung cancer is the leading cause of cancer death among both men and women and accounts for about one-fifth of all cancer deaths.
Lung cancer is broadly split into non-small cell and small cell, with about 15 percent classified as small cell About three-quarters of small cell patients are diagnosed with the extensive-stage disease, in which the cancer has spread widely through the lung or to other parts of the body. Only six percent of all SCLC patients will be alive five years after diagnosis.
Imfinzi is also approved for previously treated patients with advanced bladder cancer in 11 countries, including the US. It is also being tested as a treatment for bladder cancer, head and neck cancer, liver cancer, biliary tract cancer, cervical cancer, and other solid tumors.
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