US FDA Continues Shift From Companion To Complementary PD-L1 Diagnostics With AstraZeneca Imfinzi Approval
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.
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While device firms that create lab test kits, clinical laboratories and cancer medicine groups supported US Centers for Medicare and Medicaid Services' proposed national coverage determination for use of next generation sequencing (NGS) for advanced cancer tests in recent comments, they want the agency to modify its approach to the NCD in one way or another and, in many cases, expand it. A final coverage decision is imminent.
In May, US FDA achieved its highest monthly total of 510(k)s clearances in more than two years. Here's a snapshot of the agency's approval and clearance activity last month from Medtech Insight's Approvals Tracker.
As many as five PD-1/L1 inhibitors will be approved for second-line metastatic disease by the end of 2017, but AstraZeneca hopes to stand apart with the combination of Imfinzi (durvalumab) with its CTLA-4 inhibitor tremelimumab.