FDA lifts partial hold on Blueprint’s CDK2 inhibitor

The FDA has lifted a partial clinical hold on Blueprint Medicines’ early-stage cancer drug, clearing the way for the biotech to dose new patients.

Blueprint flagged the hold last month, which it said was imposed due to reports of side effects related to vision. A “limited number of patients” experienced what it described as “transient, reversible episodes of light sensitivity and blurred vision” after taking BLU-222. While the FDA allowed patients already enrolled in the trial to keep receiving the drug, no new patients could be enrolled.

Becker Hewes

The biotech resolved the partial hold by updating adverse event monitoring and management procedures, CMO Becker Hewes said in a statement.

BLU-222 blocks CDK2, or cyclin-dependent kinase 2, an enzyme involved in cell cycle control. The Phase I/II trial that was put on hold, VELA, was testing the drug in a number of solid tumors, including breast, ovarian, endometrial and gastric cancer. While there are drugs on the market targeting different members of the same kinase family — namely CDK4/6 inhibitors like Novartis’ Kisqali, Pfizer’s Ibrance and Eli Lilly’s Verzenio — CDK2 is relatively unexplored.

Initial dose escalation data are expected in the second quarter of 2023, the company added, with plans to combine BLU-222 with chemotherapy, CDK4/6 inhibitors and anti-estrogen therapy.

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