Earlier this month, the FDA halted enrollment in multiple myeloma clinical trials featuring AbbVie and Roche drug Venclexta. Now, it’s officially warning doctors, researchers and patients about the drug—and dishing on the data that prompted the moves.

Regulators issued an alert Thursday detailing the risks associated with investigational use of Venclexta in myeloma—namely, an increased risk of death.

Data from a trial combining Venclexta with Takeda proteasome inhibitor Velcade and dexamethasone showed that the experimental cocktail increased the relative risk of death by about twofold compared with placebo, the FDA said. At an interim survival analysis, 41 of 194—or 21.1%—patients in the experimental arm had died, versus 11 of 97 patients (11.3%) in the placebo group.

The warning follows a recent FDA decision to place a partial clinical hold on Venclexta’s myeloma trials, effectively pressing pause on trial enrollment. Trial patients who have seen benefits can remain on the Venclexta regimen, the agency said, provided that they reconsent to participating in the trial.

It also encouraged healthcare professionals and patients to report any Venclexta side effects to its MedWatch Adverse Event Reporting program, simultaneously stressing once again that Venclexta is "safe and effective" for its approved indications in chronic lymphocytic leukemia and acute myeloid leukemia.

AbbVie and Roche—which are both counting on Venclexta to deliver key revenue as their older players come under biosimilar attack—are hoping their myeloma trials don’t go the way of Merck’s, which the FDA scuttled completely after a group of study patients taking immuno-oncology blockbuster Keytruda saw an increased rate of death. AbbVie and Roche have been working to expand Venclexta’s reach, racking up two new approvals in 2018 and posting positive CLL combo data alongside Roche’s Gazyva, too.

The companies, though, are first and foremost "committed to patient safety," AbbVie vice chairman and president Michael Severino, M.D., said in a Tuesday statement. "We will continue working with the FDA and worldwide regulatory agencies to determine appropriate next steps for the multiple myeloma program," he added.

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