FDA accepts resubmission of BLA for N-803 in NMIBC
October 26th 2023The FDA has accepted a resubmitted biologics license application for N-803 for use in combination with BCG for the treatment of patients with BCG-unresponsive non–muscle-invasive bladder cancer carcinoma in situ with or without Ta or T1 disease.
Private equity acquisition is linked with lower MIPS scores for urologists
October 23rd 2023“As private equity firms increasingly engage in urology, key stakeholders, including policymakers and urologists, need to ensure that the quality of care is not compromised with the structural changes implemented after acquisition," write the authors.
Addition of nivolumab to frontline SOC improves survival in urothelial carcinoma
October 22nd 2023Frontline therapy with nivolumab plus gemcitabine-cisplatin, followed by nivolumab maintenance, led to improved overall and progress-free survival in patients with unresectable or metastatic urothelial carcinoma.
Niraparib/abiraterone combo associated with survival benefit in BRCA+ mCRPC
October 22nd 2023Adding niraparib to abiraterone acetate and prednisone (AAP) was associated with an overall survival benefit compared with AAP alone in patients with BRCA1/2-mutated metastatic castration-resistant prostate cancer.
Belzutifan demonstrates superior PFS, ORR to everolimus in ccRCC
October 22nd 2023“Belzutifan demonstrated a significant improvement in PFS with a hazard ratio of .75, and a significant P value. Similar findings were noted at the second interim analysis with a hazard ratio of .74,” says Laurence Albiges, MD, PhD.
Addition of pembrolizumab to enzalutamide does not improve rPFS, OS in mCRPC
October 22nd 2023“Future studies should focus on patient selection and the identification of positive predictive markers of response, more so than treating all comers, which several studies have shown has not really worked here or they acknowledge it,” says Julie N. Graff, MD.
Enzalutamide data published in NEJM as FDA weighs nonmetastatic HSPC approval
October 20th 2023The phase 3 EMBARK trial showed that enzalutamide plus leuprolide reduced the risk of metastasis or death by nearly 60% vs leuprolide alone in patients with nonmetastatic hormone-sensitive prostate cancer with high-risk biochemical recurrence.
Phase 3 trial of subcutaneous nivolumab in ccRCC meets co-primary end points
October 19th 2023Data showed noninferiority of subcutaneous nivolumab to intravenous nivolumab in the time-average to nivolumab serum concentration over 28 days (Cavgd28) and the trough serum concentration at steady state (Cminss).
Molecular insights from study may yield new prostate cancer treatment strategies
October 17th 2023“Our results provide molecular insights for potential therapeutic strategies to treat prostate cancer and other AR-involved diseases by targeting AR multivalent interactions,” said Zhijie “Jason” Liu, PhD.