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
PostEra Expands Pfizer Partnership with AI Lab and ADC Collaborations
January 8th 2025The AI Lab was launched almost exactly three years ago and has produced several programs so far, at least one of which achieved its first scientific stage gate 40% faster than the teams originally forecasted.