Those in support of the US FDA’s approval this year of Biogen, Inc.’s Aduhelm (aducanumab) for the treatment of Alzheimer’s disease (AD) like to point out the parallels to the regulator’s approach in oncology, particularly in the first years of the 21st century. For example, Iressa (gefitinib), an epidermal growth factor receptor (EGFR) inhibitor, received accelerated approval in 2003 for advanced non-small cell lung cancer, despite overall response rates of around 10%, following chemotherapy.
The approval was controversial at the time, recalled Ji Li, president and chief strategy officer at AffaMed Therapeutics, a clinical stage biotech focused on neuroscience and ophthalmology during a recent Biofutures virtual event. “Back then, approval was not initially based on a biomarker, they didn’t select for EGFR receptor mutations,” said Li
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