FDA lifts hold on Blueprint cancer drug trial

March 29, 2023

Blueprint Medicines announced that the U.S. FDA has lifted the partial clinical hold placed on an early phase CDK2-vulnerable breast cancer trial.

The phase 1/2 VELA trial is testing the Cambridge, Massachusetts-based company's CDK2-inhibitor, BLU-222, in people with cyclin E aberrant cancers and estrogen receptor-positive, HER2-negative breast cancer.

Blueprint had originally hoped to present initial VELA trial dose escalation data for BLU-222 in CDK2-vulnerable cancers in the first half of 2023 but hit a snag in the plan in early February when the FDA placed a partial clinical hold on the trial due to reported visual adverse events. The AEs consisted of transient, reversible episodes of light sensitivity and blurred vision, observed in a limited number of patients.

At the time of the hold, patients already enrolled in the trial continued receiving study drug, but enrollment was paused. Now, with hold lifted, Blueprint says it is working with trial sites to reinitiate patient enrollment.

In other news for Blueprint, Roche recently opted to discontinue a collaboration, handing back the global commercialization and development rights to cancer drug, Gavreto.