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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Oncology Center of Excellence’s ‘industry-wide evaluation’ of accelerated approvals leads to removal of indications for two PD-1/L-1 inhibitors, AstraZeneca’s Imfinzi and Bristol-Myers Squibb’s Opdivo, both of which had failed confirmatory trials.
Keeping track of US FDA approvals last week included watching the creative and the familiar.
The latest drug development news and highlights from our US FDA Performance Tracker.