FDA lifts hold on Blueprint Medicines' BLU-222 trial

The US Food and Drug Administration (FDA) has lifted a partial clinical hold on the Phase I/II VELA trial of BLU-222, said the drugs developer, Blueprint Medicines (Nasdaq: BPMC), sending the US biotech’s shares up 4% to $42.57.

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.

The FDA lift means that Blueprint is cleared to continue further dosing in the trial, which is investigating BLU-222, a selective inhibitor of CDK2, as a treatment for patients with solid tumors.