On March 28, 2023 Blueprint Medicines Corporation (NASDAQ: BPMC) reported that the U.S. Food and Drug Administration (FDA) has lifted a partial clinical hold on the Phase 1/2 VELA trial of BLU-222 (Press release, Blueprint Medicines, MAR 28, 2023, View Source [SID1234629434]).

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On February 10, 2023, Blueprint Medicines announced the FDA placed a partial clinical hold on the VELA trial due to reported visual adverse events, consisting of transient, reversible episodes of light sensitivity and blurred vision, observed in a limited number of patients. Patients already enrolled in the trial have continued receiving study drug. The partial clinical hold is lifted as of March 28, and Blueprint Medicines is working with trial sites to reinitiate patient enrollment.

"With a focus on patient safety, we have worked diligently with the FDA over the last several weeks to resolve the partial clinical hold by updating adverse event monitoring and management procedures. We will now collaborate closely with investigators to resume patient enrollment," said Becker Hewes, M.D., Chief Medical Officer at Blueprint Medicines. "We are confident in the potential of BLU-222 to improve outcomes in patients with cancers vulnerable to CDK2 inhibition, and we look forward to presenting initial dose escalation data from the VELA trial in the second quarter of 2023.