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.

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