The US Food and Drug Administration (FDA) has lifted the partial clinical hold placed on AbbVie’s CANOVA (M13-494), a Phase III trial evaluating venetoclax to treat relapsed / refractory multiple myeloma.
In March this year, the FDA placed a clinical hold on all trials evaluating venetoclax following a review of data from the Phase III BELLINI trial in relapsed / refractory multiple myeloma.
Venetoclax is being developed by AbbVie and Roche.
AbbVie said that a higher proportion of deaths were observed in the venetoclax arm of the study when compared to the control arm.
The FDA removed the hold on the trial based on the agreement of revisions to the multi-centre, randomised, open-label CANOVA study protocol, including new risk mitigation measures, protocol-specified guidelines, and updated futility criteria.
AbbVie can now restart enrolment in the CANOVA trial as determined by each participant site based on the approved protocol.
The trial will evaluate venetoclax in combination with dexamethasone versus pomalidomide in combination with dexamethasone in patients with relapsed / refractory multiple myeloma positive for the translocation (11;14) abnormality.
AbbVie Hematology Development global head Mohamed Zaki said: “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.
“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.”
All other clinical trials that are currently evaluating venetoclax remain on partial clinical hold.
Venetoclax is jointly commercialised by AbbVie and Roche Group member Genentech in the US and by AbbVie outside of the US.
Earlier this month, AbbVie and Roche reported that the combination of venetoclax with obinutuzumab prolonged progression-free survival in the Phase III CLL14 trial of treatment-naïve chronic lymphocytic leukaemia (CLL) patients.