Blueprint Medicines BLU-222 Study on FDA Partial Hold
February 10 2023 - 8:49AM
Dow Jones News
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 colin.kellaher@wsj.com
(END) Dow Jones Newswires
February 10, 2023 08:34 ET (13:34 GMT)
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