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FDA Lifts Partial Clinical Hold on Venetoclax Myeloma Trial

Gina Columbus @ginacolumbusonc
Published: Monday, Jun 24, 2019

blood cellsD The FDA has lifted a partial clinical hold that was placed on the phase III CANOVA (M13-494; NCT03539744) trial, which is examining venetoclax (Venclexta) in combination with pomalidomide (Pomalyst) and dexamethasone in patients with relapsed/refractory multiple myeloma that harbors t(11;14), according to AbbVie, the company that co-develops the BCL-2 inhibitor with Roche.1

The lift on the partial hold is based on an agreement on revisions to the CANOVA study protocol, which includes new risk mitigation measures, protocol-specified guidelines, and fully updated criteria.

"We are pleased to move forward with the CANOVA study which, with the t(11;14) biomarker test, can help identify patients who may respond better to treatment and add clarity for physicians when choosing a therapy, if approved," Mohamed Zaki, MD, PhD, global head of hematology development at AbbVie, stated in a press release. "We are working closely with regulatory authorities worldwide to continue our efforts to understand the potential of venetoclax for patients with multiple myeloma while continuing to advance research in patients with the t(11;14) genetic abnormality."

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