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FDA investigating possible increased risk of death with lymphoma medicine Ukoniq (umbralisib)

• The U.S. Food and Drug Administration (FDA) is investigating a possible increased risk of death with the cancer medicine Ukoniq (umbralisib) approved to treat two specific types of lymphomas, which are cancers that affect the body’s immune system.
• FDA determined that initial findings from a clinical trial evaluating Ukoniq to treat a related type of cancer found a possible increased risk of death in patients taking the medicine. Because of the seriousness of this safety concern and the similarities between the two types of cancer for which this drug is approved and the type of cancer that was studied in the clinical trial, FDA is alerting patients and health care professionals that FDA is re-evaluating this risk against the benefits of Ukoniq for its approved uses.
• FDA is continuing to evaluate the results from the clinical trial called UNITY.
• FDA may also hold a future public meeting to discuss these findings and explore the continued marketing of Ukoniq.
• FDA has also suspended enrollment of new patients in other ongoing clinical trials of Ukoniq while it continues to review the UNITY findings. 
• FDA will communicate the final conclusions and recommendations when it has completed the review or has more information to share.

Pivotal Single-Arm Ph 3 Trial for UGN-102 initiated in patients with Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
“The start of the ENVISION trial marks the final phase of validating primary chemoablation for the treatment of recurrent intermediate risk NMIBC,” said Sandip Prasad, Urologist, Atlantic Health System, Morristown Medical Center, NJ, and lead study investigator for the ENVISION trial. “This study is designed to support the clinical potential of UGN-102 as a new treatment for patients that are under-served by the current standard of care, including those patients at risk for recurrence and those that are unwilling or unable to endure surgery or anesthesia.”

 

Cancer Moonshot initiative re-kindled by Biden administration
Cancer Moonshot Task Force, established in 2016 by Obama administration with the then Vice President Joe Biden at the helm, has reconvened to realize the visions of the project by next 25 years, aiming to reduce cancer death rate by 50 percent in the next 25 years by improving prevention, screening, and research. According to a recent release by Biden administration, “ it’s now possible to set ambitious goals: to reduce the death rate from cancer by at least 50 percent over the next 25 years, and improve the experience of people and their families living with and surviving cancer— and, by doing this and more, end cancer as we know it today”, leveraging the recent advancement in diagnostics and patient-centric care. A White House Cancer Moonshot coordinator in the Executive Office of the President will be named, who will be in charge of forming a Cancer Cabinet consisting of different departments and agencies to address cancer on multiple fronts. White house also plans to proceed with a  Cancer Moonshot Summit to build upon the White House Cancer Roundtable Conversation Series the administration has been hosting over the last six months.

Veru Enters into Clinical Trial Collaboration and Supply Agreement with Eli Lilly to Evaluate Enobosarm in Combination with Verzenio® in Ph 3 ENABLAR-2 Trial
“Independently conducted proof of concept preclinical studies in human breast cancer models have demonstrated that the combination of enobosarm with a CDK4/6 inhibitor had greater antitumor synergistic activity in tumor samples from patients who had breast cancer progression following treatment with palbociclib, a CDK4/6 inhibitor, and an estrogen blocking agent. The ENABLAR-2 trial will evaluate the efficacy and safety of the enobosarm and abemaciclib combination in patients that have previously received first line therapy of palbociclib and estrogen blocking agent combination in AR+ER+HER2- metastatic breast cancer,” said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru Inc. “We are excited about potentially being an oral 2nd line therapeutic option in combination with abemaciclib for patients who have AR+ER+HER2- metastatic breast cancer. We are looking forward to our collaboration with Lilly on the ENABLAR-2 clinical trial.”