FDA challenges safety, efficacy of Geron's imetelstat ahead of advisory committee meeting
The FDA said Tuesday that it is unconvinced the benefits of Geron’s imetelstat outweigh the risks in certain anemic myelodysplastic syndrome (MDS) patients who are dependent on blood transfusions.
Regulators raised a list of safety and efficacy concerns in briefing documents published ahead of Thursday’s Oncologic Drugs Advisory Committee meeting, including that the only randomized efficacy trial for imetelstat enrolled just 13 patients in the US.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.
