FDA Slaps Partial Clinical Hold On Blueprint Medicines' Early-Stage Solid Tumor Study

  • The FDA has placed a partial clinical hold on Blueprint Medicines Corporation's BPMC 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 continue on the study drug, and additional patients will not be enrolled until the partial clinical hold is resolved.
  • Also Read: Blueprint Medicines Stock Gets Price Target Cut Amid Lower Than Expected Ayvakit Uptake.
  • 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 were resolved with dose interruption or reduction. 
  • No treatment-emergent abnormal findings, including uveitis, have been observed in patients who have received detailed ophthalmologic examinations.
  • 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.
  • "We have confidence in the benefit-risk profile of BLU-222 based on the activity and safety data we have seen to date in the dose escalation study," said Becker Hewes, Chief Medical Officer.
  • Price Action: BPMC shares are down 7.88% at $40.80 during the premarket session on the last check Friday.
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