FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Orders AbbVie to Stop Recruiting in Myeloma Trial After Deaths Spike

March 28, 2019
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The FDA ordered AbbVie to stop recruiting multiple myeloma patients for a Phase III trial of its anti-cancer drug Venclexta/Venclyxto.

Forty-one out of 194 patients taking AbbVie’s Venclexta (venetoclax) in the company’s trial have died, the FDA found, nearly twice the percent of the patients in the trial’s placebo arm.

Venclexta is already approved for chronic lymphocytic leukemia and acute myeloid leukemia but the halt doesn’t affect any patients outside the multiple myeloma experiments, and AbbVie said it “remains confident in the benefit/risk profile” of the drug.

AbbVie has high hopes for Venclexta, which is the first oral, chemotherapy-free cocktail. It originally debuted in 2016 as a treatment for chronic lymphocytic leukemia (CLL) patients who had a rare genetic mutation. After Venclexta was approved for CLL patients in combination with Roche’s Rituxan, AbbVie officials said they expected to reap as much as $3 billion in sales over the next decade.

There are currently 291 patients enrolled in AbbVie’s BELLINI trial, a randomized, double-blind study that involves some 97 sites around the U.S. Patients who have relapsed or refractory multiple myeloma and who have received between one to three lines of therapy are given bortezomib and dexamethasone in combination with either Venclexta or a placebo.

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