Biotech Values

[DewDiligence]

AZN—FDA approves Imfinzi for Stage-III NSCLC:

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm597217.htm

The U.S. Food and Drug Administration today approved Imfinzi (durvalumab) for the treatment of patients with stage III non-small cell lung cancer (NSCLC) whose tumors are not able to be surgically removed (unresectable) and whose cancer has not progressed after treatment with chemotherapy and radiation (chemoradiation).

“This is the first treatment approved for stage III unresectable non-small cell lung cancer to reduce the risk of the cancer progressing, when the cancer has not worsened after chemoradiation,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

No other PD-(L)1 drug has been tested in a phase-3 trial in this patient population, although the other PD-(L)1 drugs on the market would presumably work as well as Imfinzi.