FDA approves Imfinzi for extensive-stage SCLC

AstraZeneca has announced that Imfinzi (durvalumab) has been approved by the US Food and Drug Administration (FDA) as 1st-line treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC).

The pharma giant reported that the drug has been approved in combo with standard-of-care (SoC) chemotherapies, etoposide and either carboplatin or cisplatin (platinum-etoposide).

The approval, based on positive results from the Phase III CASPIAN trial, "brings a new medicine to extensive-stage small cell lung cancer patients in urgent need of new options" commented Dave Fredrickson, executive vice president, Oncology Business Unit.

In the trial, the risk of death was reduced by 27% with median overall survival (OS) of 13.0 months versus 10.3 months for SoC alone.

Fredrickson added that the human monoclonal antibody "is the only immunotherapy to show both a significant survival benefit and improved response rate in combination with chemotherapy for these patients, an important step forward in treating this devastating disease."

Results also showed an increased confirmed objective response rate in the Imfinzi plus SoC arm, with 68% versus 58% for SoC alone.

The company also confirmed that the second experimental arm testing tremelimumab added to Imfinzi and SoC recently read out but did not meet the primary endpoint.

Lung cancer is the leading cause of cancer death among both men and women and accounts for about one-quarter of all cancer deaths in the United States.

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