Other safety alerts
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| The United States: FDA Warns about the risks associated with the investigational use of Venclexta in Multiple Myeloma |
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The US Food and Drug Administration (FDA) is alerting health care professionals, oncology clinical investigators and patients about the risks associated with the investigational use of Venclexta (venetoclax) for the treatment of patients with multiple myeloma based on data from a clinical trial. Venclexta is not approved for the treatment of multiple myeloma.
FDA reviewed data from the BELLINI clinical trial (NCT02755597, Study M14-031) evaluating the use of Venclexta combined with bortezomib, a proteasome inhibitor, and dexamethasone in patients with multiple myeloma. The interim trial results demonstrated an increased risk of death for patients receiving Venclexta as compared to the control group. On 6 Mar 2019, the FDA required no new patients be enrolled on the BELLINI trial. Patients who are receiving clinical benefit can continue treatment in the trial after they reconsent. More information about the BELLINI clinical trial findings can be found in the website in FDA.
This statement does not apply to patients taking Venclexta for an approved indication. Patients taking Venclexta for an approved indication should continue to take their medication as directed by their health care professional. Venclexta is safe and effective for its approved uses.
The FDA suspended enrollment in other ongoing multiple myeloma clinical trials of Venclexta. Patients who are receiving clinical benefit can continue treatment in these trials after they reconsent. FDA will be working directly with sponsors of Venclexta, as well as other investigators conducting clinical trials in patients with multiple myeloma, to determine the extent of the safety issue. The agency will communicate any new information as appropriate.
Please refer to the following website in FDA for details:
http://www.fda.gov/Drugs/DrugSafety/ucm634120.htm
In Hong Kong, Venclexta Tablets 10mg (HK-65284), Venclexta Tablets 50mg (HK-65283) and Venclexta Tablets 100mg (HK-65285) are registered pharmaceutical products containing venetoclax. All products are registered by Abbvie Limited, and are prescription-only medicines. So far, the Department of Health (DH) has not received any case of adverse drug reaction related to venetoclax. As the review of the trial data is ongoing, the DH will remain vigilant on the results of the trial and safety update of the drug issued by FDA and other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/Friday, Mar 22, 2019
Issued at HKT 16:00
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