• FDA removed the partial clin­i­cal hold based upon agree­ment on revisions to the CANOVA study protocol, in­clud­ing new risk mitigation measures, protocol-specified guidelines and updated futility criteria
• The t(11;14) genetic bio­marker is among the most common and routinely tested genetic ab­nor­mal­i­ties in patients with multiple myeloma¹

North Chicago, IL (Press Release) – AbbVie (NYSE: ABBV), a research-based global bio­pharma­ceu­tical com­pany, today announced that the U.S. Food and Drug Admin­istra­tion (FDA) has lifted the partial clin­i­cal hold placed on CANOVA (M13-494), a Phase 3 trial eval­u­ating veneto­clax (VENCLEXTA® OR VENCLYXTO®) for the inves­ti­ga­tional treat­ment of re­lapsed / refractory multiple myeloma. The CANOVA trial eval­u­ates 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. The t(11;14) genetic bio­marker …

North Chicago, IL (Press Release) – AbbVie (NYSE: ABBV), a research-based global bio­pharma­ceu­tical com­pany, today announced the U.S. Food and Drug Admin­istra­tion (FDA) has placed a partial clin­i­cal hold on all clin­i­cal trials eval­u­ating veneto­clax (VENCLEXTA®/​VENCLYXTO®) for the inves­ti­ga­tional treat­ment of multiple myeloma. The partial clin­i­cal hold follows a review of data from the ongoing Phase 3 BELLINI trial (M14-031), a study in re­lapsed / refractory multiple myeloma, in which a higher proportion of deaths was observed in the veneto­clax arm compared to the control arm of the trial. As a result of …

Good morning, myeloma world.

There are times when we write an edition of Myeloma Morning, and it turns out completely different than expected. Today's edition is a perfect example.

As we were planning today's report, we thought it would focus on two preclinical research studies examining the potential new myeloma therapies CCF642 and BDA-366.

And, yes, we do start today's report with summaries of those two studies.

But readers will be making a mistake if they stop after reading that section of today's article. Because the third study we …