Hannah Clarke

WNT9B E152K was associated with a 2.5-fold increase in the risk of prostate cancer and reached genome-wide significance.

Overall, the open-label phase 1/2 study is assessing the safety and anti-tumor activity with INKmune across 3 dose levels.

Check out the key regulatory decisions set to happen early this year.

According to the authors, these findings highlight the need to more effectively include Black men in prostate cancer research.

If approved, the marketing authorization application would be valid in all 27 European Union member states as well as in Iceland, Liechtenstein, and Norway.

64Cu-SAR-bisPSMA was previously granted a fast track designation in August 2024 for PET imaging of PSMA-positive prostate cancer lesions in patients with suspected metastasis who are candidates for initial definitive therapy.

Overall, 39% of those who received a university-formatted report and 56% of those who received a VA-formatted report were able to identify that they had prostate cancer.

At 25 weeks, FACT-P total score remained comparable between the arms.

"[The] full integration [of genomic classifier tests] into clinical practice requires additional research to better understand their cost-effectiveness, clinical utility, and impact on diverse populations," says Amir Alishahi Tabriz, MD, PhD, MPH.

"The three-year durability data from this study further validate the potential of JELMYTO in providing long-term disease control for patients with low-grade upper tract urothelial cancer,” says Solomon L. Woldu, MD.

The accuracy of PLND was 93.41% in the ICG injection arm compared with 75.91% in the control arm.

The median time to correct treatment was 98 days with initial TURBT compared with 53 days with initial mpMRI.

Functional success was achieved in 58% of patients at 5-year follow-up.

At a median follow-up of 24.3 months, the confirmed objective response rate was 70%.

The 15 drugs identified in this round of negotiations add to the 10 selected in the first round of negotiations that took place in 2023 and 2024.

The European approval of Illuccix adds on to prior approvals in the US, Australia, and Canada.

In total, 40.3% of patients experienced a change in staging between initial assessment on conventional imaging and PSMA PET.

The planned sBLA will seek approval of Anktiva for patients with BCG-unresponsive NMIBC in the papillary indication.

The NDA is supported by data from cohort 2 of the phase 2b SunRISe-1 trial.

The Mona Lisa 2.0 platform has been previously approved in the US, Australia, and Singapore.

“In this phase 2 study, an image-guided adaptive strategy enabled radiotherapy dose escalation to over 86% of patients’ bladder tumors without significant increase in toxicity,” wrote the authors.

In a recent study of the RELIEF stent, 95% of patients showed no VUR following stent placement.

The PDUFA target action date has been set for August 29, 2025.

The Expander-2 trial is intended to provide data that will support submission of the device for regulatory approval.

The test can provide results in 48 minutes for diagnostic insights for conditions such as hypogonadism, impotence, polycystic ovarian syndrome, and other androgenital syndromes.

"We expect to initiate patient dosing in the second quarter of this year, with initial three-month [complete response] data to follow," says Doug Warner.

9MW2821 was previously awarded a breakthrough therapy designation as a monotherapy for locally advanced or metastatic urothelial carcinoma.

Following an initial dose of VIR-5500 of 120 µg/kg or higher, all patients achieved a PSA reduction.

At a median follow-up of 33.2 months, the confirmed objective response rate was 73.2%.

The NMPA’s approval was supported by data from the phase 3 EV-302 trial.