1. Pink Sheet

Pfizer’s Ibrance And The Realities Of 'Real-World' Evidence

 
• By Michael McCaughan

US FDA approved expanded label for male breast cancer based on a supplement that included only non-traditional data sets. But agency is making clear that the “substantial” evidence for efficacy still came from the traditional pivotal trials – in women.

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The US FDA's reliance on real-world evidence may have been less than meets the eye in the case of the supplemental indication for Pfizer’s Ibrance.

The US Food & Drug Administration’s recent approval of Pfizer Inc.’s Ibrancefor use in male breast cancer is a milestone of sorts for applying real-world data to regulatory decisions: the supplemental NDA was entirely composed of non-traditional “real-world” datasets.

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