FDA Pulls Cancer Drug Approvals Due to Safety Concerns
Safety concerns have prompted the FDA to withdraw approval of umbralisib (Ukoniq)
On June 1, 2022, the U.S. Food and Drug Administration withdrew its approval for the cancer medicine umbralisib (Ukoniq) permitted for the treatment of adults with marginal zone lymphoma (MZL) and follicular lymphoma (FL), the agency announced in a safety communication. FDA officials have determined the risks outweigh the benefits of treatment based on review of a randomized, phase 3 clinical trial, which showed a possible increased risk of death in patients taking the medicine.
Because of the seriousness of the safety concerns, the drug’s manufacturer, TG Therapeutics, has removed Ukoniq from the market. Furthermore, the FDA is alerting health care professionals to stop prescribing the medication and to shift patients to alternative treatments.
Under accelerated approval, Ukoniq first entered the market in February 2021. However, the continued approval of the medication hinged on the verification of benefits through a confirmatory clinical study. An initial review of the safety clinical trial in patients with chronic lymphocytic leukemia (CLL) called UNITY posed concern – showing an increased risk of death with the use of Ukoniq. The safety concerns prompted the FDA to issue a safety communication that published their investigation and announced suspended enrollment of new patients in other ongoing clinical trials while the FDA continued to reevaluate the medication’s risks.
On June 1, 2022, the government agency updated its earlier safety communication and officially withdrew its approval of Ukoniq. It was determined by the FDA that those receiving a combination of Ukoniq and ublituximab (an investigational the monoclonal antibody) in the UNITY trial were experiencing more serious adverse effects compared to the control group. Although this study examined patients with CLL, the agency was concerned that those findings could have implications for patients prescribed solely Ukoniq. This recent FDA action formalizes an April 15, 2022 announcement by TG Therapeutics that removed Ukoniq from sale as well as withdrew their pending, supplemental biologics license application for the treatment of adults with chronic lymphocytic leukemia and small lymphocytic lymphoma.
Ukoniq is a prescribed oral medication used to treat adults with marginal zone lymphoma (MZL) when the disease has relapsed or is unresponsive to other treatments. Ukoniq is also approved as treatment for individuals with follicular lymphoma. Lymphoma is a cancer of the lymphatic system, which is part of the body’s infection-fighting network. Both MZL and FL are slow-growing cancers that begin in lymphocytes. Ukoniq is classified as a PI3 kinase inhibitor, which works by blocking the action of an abnormal protein, therefore helping stop the spread of cancer.
PI3k inhibitors have been under recent scrutiny after several have been removed from the market for observed toxicities in the drug class. Despite the class of medicine yielding promising responses and improved progression-free survival in patients with hematologic cancers, the FDA Oncologic Drugs Advisory Committee (ODAC) panel cited that “randomized data in this class of drug highlighted a high rate of fatal adverse effects and other serious AEs compared with single-arm research”. In response to safety concerns among the entire class of PI3K inhibitors, the ODAC voted 16-0 in favor of requiring future approvals of PI3K inhibitors being supported by randomized data.
In connection with this recent Ukoniq drug recall, the product liability attorneys of Meyers & Flowers are investigating possible Ukoniq drug injury lawsuits against TG Therapeutics for cases involving serious side effects of patient death caused by Ukoniq. Please contact our team at (630) 232-6333 or fill out our free case evaluation to see if you are eligible to file a Ukoniq lawsuit to recover damages.