logo
Plus   Neg
Share
Email

AbbVie: FDA Places Partial Clinical Hold On Clinical Trials Of Venetoclax In Treatment Of Multiple Myeloma

AbbVie (ABBV) said the U.S. Food and Drug Administration has placed a partial clinical hold on all clinical trials evaluating venetoclax or 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 this action, no new patients should be enrolled in any studies of venetoclax for multiple myeloma until a further analysis of the data is completed. Patients who are currently enrolled in studies and receiving benefit from the therapy may continue with treatment, after consultation with their physician, the company said.

This action does not impact any of the approved indications for venetoclax, such as chronic lymphocytic leukemia (CLL) or acute myeloid leukemia (AML), and is limited to investigational clinical trials in multiple myeloma. AbbVie remains confident in the benefit/risk profile of venetoclax in those approved indications.

Venetoclax is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
U.S. President Donald Trump said he discussed with Apple Inc.'s CEO Tim Cook about the impact of the U.S. tariffs on goods imported from China as well as the competition for Apple from South Korea's Samsung Electronics Co. Cook reportedly warned Trump that the tariffs on Chinese imports would hurt Apple's business as the tech giant relies heavily on manufacturing in China. Just Egg, a plant-based egg alternative, will be available in 2,100 stores owned by grocery chain Kroger Co. later this month. The product launch comes as plant-based meat and egg alternatives gain traction in the country. Just Egg, a product of California-based food technology company Just Inc., will be available at Kroger-owned stores, including Kroger, Fred Meyer and Ralphs. Boeing has delivered the first 787-10 Dreamliner to Vietnam Airlines, the flag carrier of Vietnam, as part of the eight 787-10 Dreamliner airplanes to be delivered on lease through Air Lease. Vietnam Airlines said the 787-10 Dreamliner, claimed by Boeing to be the most fuel-efficient twin-aisle airplane in the industry, will help it raise the customer experience on the Hanoi to Ho Chi Minh route.
Follow RTT