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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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Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

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