Blueprint Medicines Says FDA Places Partial Clinical Hold On Phase 1/2 VELA Trial Of BLU-222
(RTTNews) - Precision therapy company Blueprint Medicines Corp. (BPMC) announced Friday that the U.S. Food and Drug Administration (FDA) verbally informed the company on Wednesday that it has placed a partial clinical hold on the Phase 1/2 VELA trial of BLU-222 due to visual adverse events (AEs) observed in a limited number of patients.
Patients currently enrolled in the trial are continuing on study drug at this time, and additional patients will not be enrolled until the partial clinical hold is resolved.
BLU-222 is currently being evaluated in the Phase 1 dose escalation portion of the VELA trial. Patients have been treated with BLU-222 at doses ranging from 50 mg BID to 800 mg BID to date, with evidence of clinical benefit observed and no discontinuations due to AEs.
The reported visual AEs consisted of transient, reversible episodes of light sensitivity and blurred vision. All events were Grade 1, except one Grade 3 event involving light sensitivity and blurred vision in a patient treated at 600 mg BID. All events resolved with dose interruption or reduction.
Consistent with prior guidance, Blueprint Medicines plans to present initial dose escalation data from the VELA trial of BLU-222 in the first half of 2023.
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