NYU LANGONE HEALTH

FDA Approves First At-Home Cervical Cancer Screening Test, Expanding Access to Preventive Care

13 days ago

• Teal Health's Teal Wand has received FDA approval as the first at-home cervical cancer screening test, offering an alternative to in-clinic pap smears for women aged 25-65 at average risk. • Clinical trials demonstrated the self-collected samples using the Teal Wand perform with 96% accuracy compared to clinician-collected samples, potentially addressing the issue that one in four women falls behind on cervical cancer screening. • The device, which works similarly to a tampon applicator, will be available for shipping starting in June in California before expanding nationwide, with the company working with major insurance providers on coverage options.

Genprex Secures Exclusive License for REQORSA Gene Therapy in Glioblastoma Treatment

16 days ago

• Genprex has entered into an exclusive patent license agreement with UTHealth Houston for its REQORSA gene therapy to treat glioblastoma, expanding beyond its established lung cancer applications. • Preclinical studies demonstrated that REQORSA significantly reduced glioblastoma cell viability and suppressed cancer cell migration by restoring TUSC2 expression, a novel tumor suppressor for this deadly brain cancer. • The agreement grants Genprex exclusive commercial rights to REQORSA for glioblastoma, addressing a significant unmet medical need for the most common and aggressive primary brain tumor in adults.

ctDNA Monitoring Shows Promise for Predicting Melanoma Recurrence After Surgery

a month ago

• Circulating tumor DNA (ctDNA) monitoring can reliably identify minimal residual disease in patients with resected stage III melanoma, predicting high risk of early recurrence even when patients appear disease-free by radiographic measures. • In the phase 3 COMBI-AD trial, patients with detectable ctDNA had significantly shorter recurrence-free survival compared to ctDNA-negative patients, with the effect observed in both placebo and targeted therapy groups. • ctDNA analysis outperformed traditional prognostic indicators like tumor substage, interferon gamma expression, and tumor mutational burden, suggesting potential for integration into post-surgical surveillance and treatment decision-making.

FDA to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Drugs

a month ago

• The FDA announced it will phase out requirements for animal testing of monoclonal antibodies and other drugs, citing the availability of "more effective, human-relevant methods" for safety evaluation. • The initiative aims to improve drug safety, accelerate evaluation processes, reduce R&D costs, and ultimately lower drug prices by implementing AI-based computational models, humanoid models, and real-world human data. • This regulatory shift, enabled by the bipartisan FDA Modernization Act 2.0 of 2022, represents what FDA Commissioner Marty Makary calls "a paradigm shift in drug evaluation" that could expedite development of new treatments.

BRCA2 Mechanism Reveals Why PARP Inhibitors Work in Only Some Cancer Patients

2 months ago

• NYU Langone researchers have discovered that BRCA2 acts as a molecular shield preventing PARP1 from binding to DNA damage sites, explaining why PARP inhibitors are effective only in certain cancer patients. • The study, published in Nature, used advanced single-molecule imaging to reveal how BRCA2 ensures RAD51 protein can access DNA repair sites instead of PARP1, preventing treatment-generated DNA breaks in resistant cancer cells. • This breakthrough explains variable patient responses to PARP inhibitors like olaparib, which have shown effectiveness in pancreatic, prostate, breast, and ovarian cancers with BRCA mutations, pointing to the need for patient-specific tumor profiling.

Nutrition's Critical Role in Cancer Care: From Prevention to Survivorship

2 months ago

• Nutrition plays a vital role throughout the cancer journey, with different dietary strategies needed during active treatment versus survivorship and prevention phases. • Recent research highlights the link between obesity and processed foods with increased cancer risk, with many oncologists now recommending Mediterranean-style diets rich in colorful fruits and vegetables. • Multidisciplinary care teams including dietitians are essential for managing treatment-related symptoms and developing sustainable, evidence-based nutrition plans that improve long-term outcomes.

GLP-1 Agonists Show Significant Benefits for Kidney Transplant Recipients with Type 2 Diabetes

3 months ago

• A landmark study by NYU Langone Health reveals kidney transplant recipients with type 2 diabetes who take GLP-1 agonists experience 49% lower risk of organ failure and 31% reduced mortality within five years. • While the anti-obesity medications demonstrated substantial benefits, researchers observed a 49% increased risk of diabetic retinopathy, highlighting the need for careful eye health monitoring in these patients. • The comprehensive analysis of 18,016 kidney transplant recipients provides the strongest evidence to date supporting GLP-1 agonists as safe and effective tools for managing diabetes in transplant patients.

VAPOR 2 Trial Completes Enrollment: Testing Novel Water Vapor Ablation Device for Prostate Cancer

3 months ago

• Francis Medical has successfully completed enrollment of 235 patients across 26 US sites in the pivotal VAPOR 2 trial, evaluating the Vanquish Water Vapor Ablation device for intermediate-risk prostate cancer. • The Vanquish device, which received FDA Breakthrough Device Designation in 2023, uses innovative water vapor technology to deliver targeted thermal energy to cancerous prostate tissue. • The trial will track patients for up to 5 years, with primary endpoints focusing on disease control at 36 months and urinary continence at 12 months.

Study Reveals Significant Racial and Ethnic Disparities in Psoriatic Arthritis Care and Research

3 months ago

• Historical misconception of psoriatic arthritis as a "Caucasian disease" has led to potential underdiagnosis and misdiagnosis in non-White populations, particularly due to varying presentation across different skin tones. • Recent NHANES data shows significant psoriasis prevalence across multiple ethnic groups: 3.6% in White, 2.5% in Asian, 1.9% in Hispanic, and 1.5% in Black individuals. • NYU Langone researchers highlight critical gaps in clinical trials, where over 90% of participants are White, failing to reflect the true diverse patient population affected by the disease.

FDA Approves Clinical Trials for Pig Kidney Transplants in Humans, Addressing Organ Shortage

4 months ago

• The FDA has approved clinical trials for two companies, United Therapeutics and eGenesis, to transplant genetically modified pig kidneys into humans with kidney failure. • United Therapeutics will begin with six patients in mid-2025, potentially expanding to 50, while eGenesis will start with three patients, monitoring them closely. • These trials aim to address the critical shortage of donor kidneys, with over 550,000 Americans facing kidney failure and approximately 100,000 on the transplant waiting list. • Both companies have genetically modified pig genes to reduce organ rejection and improve compatibility with human bodies, but ethical and safety concerns persist.

GLP-1 Receptor Agonists Not Linked to Increased Suicide Risk, Study Finds

5 months ago

• A nationwide study in France found no increased risk of suicide or suicide attempts associated with GLP-1 receptor agonists (GLP-1 RAs). • The research included patients with psychiatric disorders and obesity, addressing a gap in previous clinical trials. • The study used a case-time-control design to account for confounding factors and exposure-trend bias, enhancing the reliability of the findings. • Results showed a negative association between GLP-1 RA use and suicidal behaviors, suggesting short-term psychiatric safety.

FDA Approves Journavx, a Novel Non-Opioid Painkiller, Offering New Hope for Acute Pain Management

5 months ago

• The FDA has approved Journavx (suzetrigine), a first-in-class non-opioid analgesic, for treating moderate to severe acute pain in adults, offering a safer alternative to opioids. • Journavx works by selectively blocking pain signals in the peripheral nervous system, reducing pain without the addictive potential and severe side effects associated with opioids. • Clinical trials demonstrated Journavx's effectiveness in reducing pain after surgeries, with a safety profile comparable to placebo, though it didn't outperform opioid-acetaminophen combinations. • Priced at $15.50 per pill, Journavx faces challenges in accessibility due to its higher cost compared to generic opioids, but it represents a significant step in combating the opioid crisis.

Xenotransplantation Advances: Pig Kidney Transplants Show Promise in Addressing Organ Shortage

5 months ago

• Towana Looney became the longest-living recipient of a pig kidney transplant, exceeding 60 days post-surgery, marking a significant milestone in xenotransplantation. • Tim Andrews received a genetically-edited pig kidney at Massachusetts General Hospital, becoming the second living person with such a transplant and is now dialysis-free. • United Therapeutics received FDA approval for a clinical trial of its UKidney, a gene-edited porcine kidney, signaling a move towards formal xenotransplantation studies. • Researchers are sharing data and refining techniques to improve the safety and efficacy of pig organ transplants, addressing the critical shortage of human donor organs.

Low-Dose Minoxidil Safely Treats Hair Loss in Women Undergoing Breast Cancer Treatment

5 months ago

• A recent study indicates that low-dose oral minoxidil (LDOM) is a safe and effective treatment for hair loss in women undergoing breast cancer treatment. • The research showed that LDOM, at a dosage of 1.25 mg per day, led to hair regrowth or stabilization of hair loss within 3 to 6 months. • The study found no serious cardiovascular side effects, even in patients who underwent chemotherapy with cardiotoxic agents. • Experts suggest that LDOM can help restore a sense of self and control for patients experiencing alopecia due to cancer treatment.

Academic and Community Partnerships Forge New Path in Comprehensive Cancer Care

6 months ago

• NYU Langone's Perlmutter Cancer Center emphasizes the critical importance of partnerships between academic institutions and community practices to deliver comprehensive cancer care beyond traditional treatments. • Healthcare leaders highlight the need for specialized support services, including dermatological care for treatment side effects and community-based organizations addressing social determinants of health. • Strategic collaborations between academic centers, community practices, and local organizations are essential for treating the whole person, not just the cancer diagnosis, while ensuring care remains accessible and patient-centered.

FDA Grants Fast Track Designation to Genascence's GNSC-001 for Osteoarthritis of the Knee

6 months ago

• The FDA has granted Fast Track designation to Genascence's GNSC-001, a gene therapy for osteoarthritis (OA) of the knee, expediting its development and review. • GNSC-001 is designed to provide long-term inhibition of IL-1, a key mediator in OA, through a single intra-articular injection. • Phase 1 trial data showed GNSC-001 was well-tolerated, with sustained IL-1Ra expression and a trend toward improved pain and function scores. • Osteoarthritis affects over 30 million Americans, and current treatments offer only short-term symptom relief without slowing disease progression.