Blueprint Still Confident In CDK2 Inhibitor Despite Partial Hold On Phase I/II Trial
The FDA placed a partial hold on the VELA study of BLU-222 due to some patients experiencing visual toxicity, but the company anticipates reporting data and said it is near identifying Phase II dose.
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The FDA placed a partial hold in February amid ocular adverse event concerns, but soon lifted it. Other CDK2 inhibitors have had ocular toxicity issues as well.
Gilead said the FDA requested a partial clinical hold on the studies as well, just over a week after the drug maker said it would not develop the magrolimab further for blood cancers.
The Phase III trial of BT524 produced positive topline results in patients with acquired fibrinogen deficiency, potentially making it the first fibrinogen concentrate to win US FDA approval for that indication.