The Vanderbilt-Ingram Cancer Center

WEDNESDAY, Sept. 18, 2024 -- Women with early stage breast cancer may now take Kisquali, a medication already approved for advanced disease, following the U.S. Food and Drug Administration's expanded approval of the treatment, drug maker Novartis announced Tuesday. “The FDA approval of Kisqali for this early breast cancer population, including those with NO [hasn't spread to nearby lymph nodes] disease, is a pivotal moment in improving our approach to care,” said Dr. Dennis Slamon , director of clinical/translational research at UCLA's Jonsson Comprehensive Cancer Center and lead investigator on the company's trial of the drug. “Today’s approval allows us to offer treatment with a CDK4/6 inhibitor [Kisquali] to a significantly broader group of people as a powerful tool that, combined with endocrine therapy, can help further minimize their risk of cancer returning,” he added in a company news release . What prompted the expanded approval? In a phase 3 clinical trial involving women with earlier stage cancers, Kisqali reduced the risk of a breast cancer coming back by 25% after three years when given along with standard treatments, which can include chemotherapy, surgery and radiation followed by hormone therapy. After four years, Kisqali reduced the risk by 28.5%, according to an updated analysis presented Monday at the European Society for Medical Oncology annual meeting in Barcelona. “We want to do everything that we can to incrementally decrease the chances of this cancer coming back,” Dr. Vandana Abramson , co-leader of the Breast Cancer Research Program at the Vanderbilt-Ingram Cancer Center in Nashville, Tenn., told NBC News. “So if a patient was already at a potentially 10% risk of the cancer coming back, this would decrease it further, down to 7%.” While Verzenio , a drug in the same class, has been approved to lower the risk of early breast cancer returning, it's only for people with a very high risk of recurrence. Kisqali will be available to a much broader group of patients, whose disease may not be as aggressive at the time of diagnosis, Novartis said. The expanded approval is for patients with HR-positive, HER2-negative breast cancer, the most common form of the disease. It's for stage 2 and 3 cases, meaning the cancer hasn’t spread beyond the breast or nearby lymph nodes. While the drug’s effects were studied for three years, research has shown that breast cancer can recur decades after diagnosis. “It would be nice to still see additional longer follow-up data to see if we are impacting just rates of early recurrences, or will we also have an impact on late recurrences?” Dr. Komal Jhaveri , a breast medical oncologist at Memorial Sloan Kettering Cancer Center in New York City, told NBC News . Still, the drug will not come cheap. “The cost, out-of-pocket, if you’re taking it for the entire three years, would be close to $300,000-$400,000,” Abramson noted. With the expanded approval, it’s more likely that insurance plans will offer coverage for the treatment, but that can still tax the health care system as a whole. “Some of the criticisms of the study have been: well, it was only a 3% benefit,” Dr. Eleonora Teplinsky , head of breast and gynecologic medical oncology at Valley Health System in New Jersey, told NBC News. “Three percent more patients benefit. What does that mean? But I think that’s then up to the patient to decide what they want to do. It’s important for them to have the option.” Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

IRVINE, Calif., Aug. 8, 2024 /PRNewswire/ -- VESICA HEALTH, INC., a leading multi-omics liquid biopsy company committed to improving the management of hematuria patients and the early detection of bladder cancer, is excited to announce the formation of its Scientific Advisory Board (SAB). The SAB comprises a distinguished group of world-renowned bladder cancer experts, who will bring invaluable insights and expertise across all phases of operations, spanning research to clinical strategies, to enhance patient care. Continue Reading "We are honored to welcome these exceptional and accomplished bladder cancer leaders to Vesica Health's Scientific Advisory Board," stated Laura Caba, MPH, President of Vesica Health. "In our commitment to supporting the clinical community and patients, we will rely on these experts. Their deep understanding of the unmet needs will guide us in our mission to elevate patient care and improve outcomes." Vesica Forms Scientific Advisory Board for the Advancement of Early Bladder Cancer Detection Post this "I am excited to join Vesica's Scientific Advisory Board and support their important mission to improve the early detection of bladder cancer," commented Sam S. Chang, MD, MBA, Professor of Urology, Patricia and Rodes Hart Chair of Urologic Surgery and Chief Surgical Officer, Vanderbilt-Ingram Cancer Center at Vanderbilt University. "This Advisory Board brings together an esteemed group of peers, and I know we all look forward to collaborating with the management team to advance Vesica's clinical programs and our shared goal of improving bladder cancer detection, treatment and ultimately outcomes." Members of Vesica's Scientific Advisory Board (in alphabetical order) include: Peter Black, MD, FACS, FRCSC, Professor, Department of Urologic Sciences at the University of British Columbia (UBC), Khosrowshahi Family Chair, Associate Director of Clinical Research at Vancouver Prostate Centre Sam S. Chang, MD, MBA, Professor, Department of Urology, Patricia and Rodes Hart Professor of Urologic Surgery, Chief Surgical Officer, Vanderbilt Ingram Cancer Center and Chief, Division of Urologic Oncology at Vanderbilt University Siamak Daneshmand, MD, Professor, Department of Urology and Director of Clinical Research at the Keck School of Medicine at the University of Southern California, as well as the Society of Urologic Oncology Fellowship Director Cheryl T. Lee, MD, Professor and Chairman, Department of Urology, Dorothy M. Davis Endowed Chair in Cancer Research, Vice President of the OSU Physicians and Faculty Group Practice at the Ohio State University Wexner Medical Center Yair Lotan, MD, Professor of Urology, Chief of Urologic Oncology, the Jane and John Justin Distinguished Chair in Urology, In Honor of Claus G. Roehrborn, M.D. and holder of the Helen J. and Robert S. Strauss Professorship in Urology at UT Southwestern Medical Center Sima P. Porten, MD, MPH, Associate Professor of Urology at the University of California at San Francisco (UCSF), and member of the multi-disciplinary Urologic Oncology team at the Helen Diller Family Comprehensive Cancer Center Gary D. Steinberg, MD, Professor, Department of Urology at Rush University in Chicago, and former Director of the Bladder Cancer program at NYU Langone and the Director of Urologic Oncology at the University of Chicago Full biographies available at: About AssureMDx™ AssureMDx is a multi-omic noninvasive urine-based DNA test designed to transform the triage of hematuria patients. By providing physicians with a precise method for identifying patients at increased risk for bladder cancer, AssureMDx facilitates immediate urological referral and clinical evaluation when needed. Importantly, the test also helps physicians effectively distinguish patients at very low risk, who may bypass invasive procedures and avoid unnecessary CT scans, thereby reducing potential radiation exposure risks. Backed by extensive research, the AssureMDx epigenetic and somatic biomarkers have been reported in 22 peer-reviewed studies involving over 6,000 patients, including multiple prospective clinical validation studies. These studies consistently demonstrate the test's robust clinical performance, notably 0.96 AUC (area under the receiver operating characteristic curve), 99% Negative Predictive Value (NPV), and 96% Sensitivity for the detection of bladder cancer in hematuria patients. Moreover, AssureMDx will provide urologists a noninvasive means to monitor bladder cancer patients at heightened risk of recurrence following treatment, thereby enhancing patient management and improving outcomes. About Vesica Health, Inc. At Vesica Health, our mission is clear: to revolutionize the management of hematuria patients, enhance the early detection of bladder cancer, and improve patient survival. Hematuria, characterized by blood in the urine, affects an estimated 17 million (1-in-5) adult Americans annually, serving as the most common symptom of bladder cancer. Despite guideline recommendations, only 12% of patients are referred to urology for clinical evaluation, resulting in approximately 20,000 diagnoses missed each year. Delayed detection leads to later-stage disease and increased mortality rates. Conventional diagnostic methods like cytology and cystoscopy, while widely used, suffer from lower sensitivity and often fail to detect bladder cancer. Moreover, the fear of undetected cancer prompts a high rate of CT scans, exposing patients to unnecessary radiation and an increased risk of secondary cancer later in life. Drawing from 20 years of advanced multi-omics research in bladder cancer detection, AssureMDx is a clinically validated, noninvasive test that helps improve the evaluation of hematuria, enhance early disease detection, and enable effective recurrence monitoring. For more information on our groundbreaking initiatives, visit . For more information: Vesica Health Corporate Communications [email protected] This company announcement contains forward-looking statements and estimates with respect to the anticipated future performance of Vesica Health and the market in which it operates. Such statements and estimates are based on assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable but may not prove to be correct. Actual events are difficult to predict, may depend upon factors that are beyond the company's control, and may turn out to be materially different. Vesica Health expressly disclaims any obligation to update any such forward-looking statements in this announcement to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based unless required by law or regulation. This company announcement does not constitute an offer or invitation for the sale or purchase of securities or assets of Vesica Health in any jurisdiction. No securities of Vesica Health may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. securities laws. NOTE: The Vesica Health wordmarks and logos, including Vesica Health, and AssureMDx are trademarks or registered trademarks of Vesica Health, Inc. All other trademarks and service marks are the property of their respective owners. SOURCE Vesica Health

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Obsidian Therapeutics, Inc., a clinical-stage biotechnology company pioneering engineered cell and gene therapies, today announced the appointment of William Pao, M.D., Ph.D., to the company’s Board of Directors as an independent member. “Dr. Pao is renowned for his groundbreaking oncology research and his executive leadership in global pharmaceutical early- and late-stage drug development and we are thrilled to welcome him to the Obsidian Board of Directors,” commented Maria Fardis, Ph.D., Chair of Obsidian’s Board of Directors. “Dr. Pao’s expertise in lung cancer will be critical as we expand OBX-115 development in both melanoma and non-small cell lung cancer.” “Obsidian’s tumor-infiltrating lymphocyte cell therapy is unique and has the potential to deliver a transformative treatment option to address the unmet need of patients with immune checkpoint inhibitor-resistant solid tumors,” added Dr. Pao. “I am excited to bring my experience in oncology drug development to Obsidian’s board and help guide the company’s next phase of growth.” “We are extremely fortunate to welcome an industry leader as distinguished as Dr. Pao to Obsidian’s Board of Directors. With his deep expertise in oncology research and a proven track record in clinical development, he will be an invaluable resource as we continue to advance OBX-115 through the clinic,” commented Madan Jagasia, M.D., Chief Executive Officer of Obsidian. Dr. Pao is recognized for his seminal research in translational medicine, mechanistic and clinical studies of targeted cancer therapeutics, cancer genomics and personalized medicine. His work helped change the standard of care for lung cancer. Dr. Pao served as Chief Development Officer and Executive Vice President for Pfizer, where he was a member of the Executive Leadership Team and led the Global Product Development organization, responsible for the clinical development and advancement of Pfizer’s pipeline. Previously, he served as the Head of the Roche Pharma Research & Early Development unit, where he oversaw the discovery and early development of new molecular entities across multiple therapeutic areas. He was a member of Roche’s Enlarged Corporate Executive Committee and founded the Roche Institute for Translational Bioengineering (now the Roche Institute for Human Biology). Previously, at Vanderbilt University’s Department of Medicine, he was a Professor of Medicine and served as the Cornelius Abernathy Craig Chair of Medical and Surgical Oncology, Director of the Division of Hematology/Oncology, and Director of Personalized Cancer Medicine at Vanderbilt-Ingram Cancer Center. Dr. Pao began his career as a practicing oncologist, lab researcher, and clinical investigator at Memorial Sloan-Kettering Cancer Center. Dr. Pao is on the Board of Directors of the American Association of Cancer Research. He is an elected member of the prestigious medical honor societies the American Society for Clinical Investigation and the Association of American Physicians. Dr. Pao is a member of the Council of Visitors of Vanderbilt University School of Medicine, where he is currently also an Adjunct Professor of Medicine. He is also an Adjunct Professor of Pharmacology and Medicine at Weill Cornell Medical College. He co-founded MyCancerGenome, an internationally recognized online tool to enable a genetically informed approach to cancer medicine. Dr. Pao received his undergraduate degree from Harvard University and his M.D. and Ph.D. degrees from Yale University. About OBX-115 Obsidian’s lead investigational cytoTIL15™ program, OBX-115, is a novel engineered tumor-derived autologous T cell immunotherapy (tumor-infiltrating lymphocyte [TIL] cell therapy) armored with pharmacologically regulatable membrane-bound IL15 (mbIL15). OBX-115 has the potential to become a meaningful therapeutic option for patients with advanced or metastatic melanoma and other solid tumors by leveraging the expected benefits of mbIL15 and Obsidian’s proprietary, differentiated manufacturing process to enhance persistence, antitumor activity, and clinical safety of TIL cell therapy. OBX-115 is being investigated in two ongoing clinical trials in advanced or metastatic melanoma and non-small cell lung cancer (NSCLC) (NCT05470283 and NCT06060613). About Obsidian Therapeutics Obsidian Therapeutics, Inc. is a clinical-stage biotechnology company pioneering engineered cell and gene therapies to deliver transformative outcomes for patients with intractable diseases. Obsidian’s proprietary cytoDRiVE® technology is designed to precisely regulate the timing and level of protein function by using FDA-approved small-molecule drugs. Obsidian is headquartered in Cambridge, MA. The Company has collaborations with Bristol Myers Squibb and Vertex Pharmaceuticals. For more information, please visit and follow us on LinkedIn.