AstraZeneca Gains EU Approval for Imfinzi to Treat ES-SCLC

September 9, 2020

Imfinzi has been granted approval in the EU for the treatment of adults with extensive-stage small cell lung cancer.

Imfinzi (durvalumab) from AstraZeneca has been granted approval in the European Union for the treatment of adults with extensive-stage small cell lung cancer (ES-SCLC) in combination with a choice of chemotherapies, etoposide plus either carboplatin or cisplatin.

The approval, which was granted by the European Commission, was based on positive results from the CASPIAN Phase III trial, showing a clinical meaningful overall survival benefit with Imfinzi plus chemotherapy in patients with ES-SCLC. The commission’s decision follows from the positive opinion that was given by the Committee for Medicinal Products for Human Use in July 2020.

“For the first time, patients with ES-SCLC in Europe will have the option of an immunotherapy combination with cisplatin, a preferred chemotherapy for many European physicians in this setting,” said Luis Paz-Ares, chair, Medical Oncology Department, Hospital Universitario Doce de Octubre, Madrid, Spain, and principal investigator in the Phase III CASPIAN trial, in a Sept. 1, 2020 press release. “[The] approval of Imfinzi provides physicians with an important new 1st-line treatment option that provides significant overall survival benefit with a well-tolerated treatment.”

Dave Fredrickson, executive vice-president, Oncology Business Unit, added in the press release, “Imfinzi plus chemotherapy is becoming a new global standard of care for patients with ES-SCLC, and we are pleased to bring this option to patients in Europe who urgently need it. This is the first immunotherapy regimen to offer both a sustained survival benefit and an improved response rate, as well as a choice of chemotherapies and convenient dosing every four weeks during maintenance.”

Source: AstraZeneca