U.S. FDA puts partial hold on Blueprint Medicines' cancer drug trial

[February 11, 2023]  By Pratik Jain

(Reuters) -Blueprint Medicines Corp said on Friday the U.S. drug regulator had put on partial hold an early-stage trial testing its experimental cancer drug due to safety concerns, sending its shares down nearly 6%.

Some patients faced episodes of light sensitivity and blurred vision, the drug developer said.

The 366-participant trial was started in April last year and was designed to check the best dose of the drug, BLU-222, for treatment of tumors such as breast cancer, ovarian cancer, endometrial cancer, among others, according to a U.S. government database.

Blueprint Medicines' Chief Medical Officer Becker Hewes said the company was working with the Food and Drug Administration to investigate the adverse events and amend the trial protocol to enable investigators to monitor and manage the events should they occur.

Wedbush Securities analyst David Nierengarten said he was encouraged by the absence of uveitis, a form of eye inflammation, in patients with the drug, something that led to a discontinuation on Nuvation Bio Inc's cancer drug study last year after an initial partial hold.

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly

"We note that uveitis occurrence is difficult to predict and remain vigilant around this safety update," Nierengarten added.

The visual issues appear to be an effect of the class to which both Nuvation Bio's and Blueprint's drugs belong, Citigroup analyst David Lebowitz said.

Patients with advanced solid tumors currently enrolled in the trial will continue on the drug, Blueprint Medicines said, while additional enrollments will be paused until the partial clinical hold is resolved.

(Reporting by Pratik Jain in Bengaluru; Editing by Dhanya Ann Thoppil, Sriraj Kalluvila and Shounak Dasgupta)

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