Blueprint Medicines BLU-222 Study on FDA Partial Hold

By Colin Kellaher

Blueprint Medicines Corp. on Friday said the U.S. Food and Drug Administration placed a partial clinical hold on the company's phase 1/2 study of BLU-222 cancer drug candidate due to vision-related adverse events in a limited number of patients.

The Cambridge, Mass., precision-therapy company said patients currently enrolled in the trial are continuing with the study drug, but that it won't enroll any additional patients until the partial hold is resolved.

Blueprint, which is studying the safety, tolerability, pharmacokinetics, pharmacodynamics and anticancer activity of BLU-222 in advanced solid tumors, said the adverse events consisted of transient, reversible episodes of light sensitivity and blurred vision, all of which were resolved with dose interruption or reduction.

The company said patients in the Phase 1, dose-escalation portion of the study have been treated at a range of doses, with evidence of clinical benefit observed and no discontinuations due to adverse events.

Blueprint said it is working with the FDA to investigate the adverse events and to amend the trial protocol to provide specific guidance to investigators on how to monitor for and manage the events should they occur.

Trading in shares of Blueprint, which closed Thursday at $44.29, was halted premarket on Friday.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

February 10, 2023 08:34 ET (13:34 GMT)

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