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US FDA Continues Shift From Companion To Complementary PD-L1 Diagnostics With AstraZeneca Imfinzi Approval

 
• By Bridget Silverman

AstraZeneca's Imfinzi (durvalumab) is the third PD-1/L1 inhibitor approved for second-line bladder cancer with labeling that describes better response rates in patients with higher PD-L1 expression, but without a requirement for diagnostic testing.

Companion Diagnostics

FDA's approval of AstraZeneca PLC's Imfinzi (durvalumab) is the latest example of the agency's growing preference for complementary diagnostics over the companion diagnostic paradigm that dominated the early days of targeted therapy and immunotherapy for cancer.

While the indications for many targeted therapies and early immunotherapy approvals specified use of a companion diagnostic test, FDA has...

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