Blueprint Still Confident In CDK2 Inhibitor Despite Partial Hold On Phase I/II Trial

Blueprint Medicines Corporation’s move into the competitive CDK2 inhibitor space has hit an obstacle as the US Food and Drug Administration has slapped a partial clinical hold on its Phase I/II VELA trial of BLU-222 due to some patients experiencing visual adverse events. But the company anticipates resolving the hold and remains on track to present dose-escalation data in the first half of 2023.

Blueprint announced the hold on 10 February, two days after it was notified by the FDA, and said the events in question included transient and reversible episodes of light sensitivity and blurred vision. It did not disclose the total number of events, but said all of the events were grade 1 in severity except one that occurred at grade 3 in a patient receiving the drug at 600mg twice daily, and all the events resolved with dose interruption or reduction