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USFDA puts partial hold on Abbvie Venclexta clinical trials after deaths


USFDA puts partial hold on Abbvie Venclexta clinical trials after deaths

The clinical hold does not impact any of the approved indications for Venclexta, such as chronic lymphocytic leukaemia (CLL) or acute myeloid leukaemia (AML), and is limited to investigational clinical trials in multiple myeloma, AbbVie said.

U.S: AbbVie Inc said on Tuesday the U.S. Food and Drug Administration placed a partial clinical hold on all trials of its cancer treatment Venclexta for multiple myeloma.

The partial hold comes after a higher number of deaths were observed in Venclexta arm compared with the control arm of a late-stage study.

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The clinical hold does not impact any of the approved indications for Venclexta, such as chronic lymphocytic leukaemia (CLL) or acute myeloid leukaemia (AML), and is limited to investigational clinical trials in multiple myeloma, AbbVie said.

Venclexta is jointly sold by AbbVie and Roche AG in the United States and by AbbVie in overseas markets.

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Source: Reuters
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