FDA lifts hold on one of AbbVie's trials of venetoclax
The U.S. Food and Drug Administration has lifted a clinical hold on one of AbbVie's Inc's trials looking at venetoclax as a potential treatment for multiple myeloma, AbbVie said Monday. The Phase 3 trial, called CANOVA, looks at venetoclax in combination with dexamethasone as a treatment for patients with advanced multiple myleoma who also have a specific genetic abnormality. The translocation abnormality, t(11;14), is one of the most commonly tested genetic abnormalities in patients with disease. AbbVie said it had agreed to revise the CANOVA study protocol, including new risk mitigation measures, protocol-specified guidelines and updated futility criteria. The drugmaker can resume enrolling patients in the CANOVA trial at sites where the protocol has been approved, but all other clinical trials of venetoclax in patients with multiple myeloma are still on hold. The FDA placed a partial hold on all of AbbVie's clinical trials of venetoclax for multiple myeloma in March. The hold came after a review of another Phase 3 trial's data showed there was a higher proportion of deaths in the treatment arm than in the control arm. Shares of AbbVie have fallen 14.6% in the year to date through Friday, while the S&P 500 has gained 17.7%.
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