PI3K Inhibitors: Overall Survival, Adverse Events And Dose Optimization Top US FDA’s Concerns

 
• By Sue Sutter

Agency will ask its Oncologic Drugs Advisory Committee whether future approvals in the class should be supported by randomized data, instead of single-arm studies, given potential overall survival detriment seen in randomized trials to date for four drugs.

Repeating pattern
There is a concerning, repeating pattern in overall survival results from PI3K randomized, controlled trials, the FDA says. • Source: Alamy

The US Food and Drug Administration is asking its Oncologic Drugs Advisory Committee to take into consideration three factors in deciding whether future approvals in the phosphatidylinositol 3-kinase (PI3K) inhibitor class should be based upon randomized data.

There exists a narrow range between effective and toxic doses in this class and, to date, the sponsors of approved...

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