Blueprint’s Experimental Cancer Drug Back in the Clinic After FDA Hold Lifted

March 29, 2023

New patients will receive Blueprint Medicine’s experimental cancer drug BLU-222 after the US Food and Drug Administration (FDA) lifted a partial hold. The agency paused dosing new patients after some participants reported vision-related adverse events. Blueprint said its updates to its protocols on adverse events were responsible for the hold being lifted.

According to Amber Tong, “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.”

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