FDA Issues Warning Regarding Investigational Use of Venclexta
March 25, 2019 - The U.S. FDA has issued a warning that the investigational use of Venclexta (venetoclax), manufactured by AbbVie and Genentech, may increase the risk of death for patients who have multiple myeloma. This applies only to the use of Venclexta in clinical studies of its application in treating multiple myeloma, for which the drug does not currently have FDA approval. According to the FDA, the new warning does not apply to patients who are taking Venclexta for an FDA-approved indication. The agency has stated that the drug is safe for approved use, and that patients should continue taking it for these uses as directed by their healthcare provider. Enrollment in clinical trials of Venclexta for the treatment of multiple myeloma has been suspended. However, patients who are currently taking the drug as part of a trial and receiving clinical benefit may continue after they reconsent. The FDA is currently working to determine the extent of the safety issue. Healthcare professionals and patients are encouraged to report any adverse events that may be associated with the use of the drug to the FDA's MedWatch program. Venclexta originally received FDA approval in 2016. It is approved to treat chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and newly diagnosed acute myeloid leukemia (AML).