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Tuesday, Dec 06, 2022

FDA lifts partial clinical hold on Gilead’s blood cancer drug trials

The health regulator had placed the hold on five cancer trials in January due to an imbalance in suspected and unexpected serious side effects between different arms of the studies that were reported by investigators of the trials.

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

Gilead Sciences Inc (GILD.O) said on Monday the U.S. Food and Drug Administration had lifted the partial clinical hold placed on its trials testing a blood cancer drug combination.

The FDA removed the hold after a review of the safety data from each trial, the company said.

The health regulator had placed the hold on five cancer trials in January due to an imbalance in suspected and unexpected serious side effects between different arms of the studies that were reported by investigators of the trials.

The trials were evaluating the combination of magrolimab and another drug azacitidine for treatment of two types of blood cancers called myelodysplastic syndrome and acute myeloid leukemia.

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Magrolimab became part of Gilead’s pipeline through the acquisition of Forty Seven Inc for $4.9 billion in 2020.

First published on: 12-04-2022 at 10:51:04 am
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