Tag Archive for: myelodysplastic syndrome

In a briefing document for Thursday’s advisory committee meeting, the FDA pointed to efficacy and safety issues with Geron’s New Drug Application for imetelstat in myelodysplastic syndromes.

The oncology company added a fifth indication for its isocitrate dehydrogenase 1 inhibitor, securing the greenlight for treating patients with IDH1-mutated relapsed or refractory myelodysplastic syndromes.

The company’s decision to scrap the deal comes after it pulled the plug on an early-stage study in August last year that was testing lemzoparlimab in combination with two other drugs for treating two types of blood cancers, myelodysplastic syndrome and acute myelocytic leukemia.

The FDA has placed a partial clinical hold on a Phase I study of Foghorn Therapeutics’ investigational protein degrader FHD-609 after a patient developed a grade 4 QTc prolongation event, the company announced Monday.

I-Mab quietly announced that its partner AbbVie is ending a Phase IB trial on lemzoparlimab for two types of cancers, despite a $2 billion deal inked in 2020.