Hannah Clarke

Data showed that the combination of EV and pembrolizumab extended overall survival and progression-free survival vs chemotherapy in patients with previously untreated locally advanced or metastatic urothelial carcinoma.

"We found that PSA levels vary by ethnicity, Black men had higher PSA levels than White men, and Asian men had the lowest PSA levels,” says Elizabeth Down.

The FIT-001 trial is assessing KO-2806 as a monotherapy and in combination with targeted therapies in patients with advanced solid tumors, including ccRCC.

“This significant milestone not only celebrates ArteraAI's success but also paves the way for the integration of AI-enabled solutions into clinical practice, illustrating their potential to enhance personalized patient care," says Andre Esteva.

The CMS payment rate for the tests went into effect on January 1, 2024.

“The test is designed to non-invasively identify the presence of aggressive cancer in men already diagnosed with prostate cancer who are on or are considering starting active surveillance,” says Kirk J. Wojno, MD.

"We looked at people who were in the intermediate-risk zone, and we found that our calculator did do a better job of helping some of those men avoid unnecessary biopsies," says Adam B. Murphy, MD, MBA, MSCI.

The study plans to enroll 144 patients with solid tumors, including RCC, non-small cell lung cancer, colorectal carcinoma (CRC), and other malignancies known to express HHLA2/B7-H7.

The guideline includes 30 recommendations related to salvage therapy for patients with biochemical recurrence following primary curative treatment for prostate cancer.

The post-market RESTORE trial plans to enroll 150 patients with urge urinary incontinence across 20 clinical trial sites in the US.

"Cretostimogene is a novel therapy which has the potential to be a paradigm shift in how we might manage the ongoing burden of this highly recurrent aspect of bladder cancer,” says Neal D. Shore, MD, FACS.

The Decipher test is a 22-gene prognostic tool used for the risk stratification of patients with localized prostate cancer.

“These clinical data show encouraging safety and efficacy with JANX007 in metastatic castration-resistant prostate cancer and with JANX008 in late-stage solid tumors," says David Campbell, PhD.

Interim data from the study showed that at 6 months following implantation, 80% (4 of 5) of evaluable women with mixed UI experienced a complete resolution of incontinence episodes.

The FDA approval is supported by data from the phase 3 ALLIUM trial, which demonstrated the non-inferiority and superiority of cefepime/enmetazobactam vs piperacillin/tazobactam.

In total, the investigators assessed data from 886 patients with advanced kidney cancer who were randomly assigned to receive avelumab plus axitinib or subitinib.

The CELC-G-201 trial is assessing the safety, preliminary efficacy, and pharmacokinetics of gedatolisib plus darolutamide in mCRPC

The FDA has issued a complete response letter regarding a new drug application for cefepime-taniborbactam for the treatment of patients with complicated urinary tract infection.

In total, the phase 1/2 PRESERVE-006 trial is expected to enroll 144 patients across 20 clinical trial sites in the US.

For 90-tablet prescriptions, the greatest costs saving were observed for solifenacin and oxybutynin, used for overactive bladder, and tadalafil, used for erectile dysfunction

Those who experienced a response with neoadjuvant chemotherapy had a median overall survival of 73.0 months, compared with 17.0 months among non-responders.

Overall, the patient met the study’s primary outcome measures of successful device activation and the rate of explants and revisions at 6 months.

Cefepime-taniborbactam is currently under review by the FDA for cUTI, including acute pyelonephritis, based on data from the CERTAIN-1 trial.

"Post-hoc sensitivity analyses from the phase 3 ARASENS trial presented at ASCO GU were consistent with and supportive of the ARASENS primary OS analysis–reinforcing darolutamide plus ADT plus docetaxel as an effective and well tolerated standard of care in patients with mHSPC," writes Neal Shore, MD, FACS.

The sNDA, which was submitted in January 2024, is supported by findings from the phase 3 EV-302 trial.

The funds will support ZERO Prostate Cancer’s Black Men’s Prostate Cancer Initiative, which provides aid to Black and Brown communities who are at higher risk of prostate cancer.

In patients where SOC imaging was unable to detect any lesions, 64Cu-SAR-bisPSMA was able to identify lesions in approximately 60% of patients on same-day imaging and up to 80% on next-day imaging.

A personalized patient genetic index will be created to show the presence of bladder cancer as well as evaluate patient response to BCG immunotherapy,” says Marvin S. Hausman, MD.

The safety and efficacy of BXCL701 in combination with pembrolizumab is currently under investigation in a phase 2 trial.

"Our findings offer hope for those looking for ways to improve their quality of life after undergoing surgery, radiation, and other common therapies for prostate cancer, which can cause significant [adverse] effects," says Stacy Loeb, MD, MSc.