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The FDA has accepted and granted a priority review to a supplemental Biologics License Application for pembrolizumab for the treatment of adult and pediatric patients with unresectable or metastatic solid tumors with tissue tumor mutational burden-high who have progressed following prior treatment and who have no satisfactory alternative treatment options.

A significant percentage of younger men with high-risk prostate cancer who display minimal comorbidities continue to receive&nbsp;nondefinitive therapy (NDT), despite research that has demonstrated local therapy is more beneficial in this patient population, according to findings from a study published in&nbsp;<em>JAMA Oncology</em>&nbsp;show. A number of reasons for this have been identified, including&nbsp;&nbsp;insurance status and race/ethnicity.

Elderly patients with advanced prostate cancer should be evaluated for preexisting cardiovascular diseases before taking oral androgen signaling inhibitors by a multidisciplinary team, includ&shy;ing a cardiologist, according to a recent retro&shy;spective study. Investigators at Thomas Jeffer&shy;son University in Philadelphia, Pennsylvania, demonstrated that after receiving abiraterone acetate&nbsp; or enzalutamide, these patients had higher rates of short-term mortality than similar patients without CVDs.

African American males with prostate cancer may fare better in terms of overall survival than Caucasian males, according to the results of a pooled analysis of phase III data. The data were obtained through the PROCEED registry, which includes over 1900 patients with metastatic castration-resistant prostate cancer treated with sipuleucel-T, created at the recommendation of the FDA.

Patients with metastatic hormone-sensitive prostate cancer with a luminal B tumor are associated with better outcomes with the addition of docetaxel chemotherapy to androgen deprivation therapy compared with androgen deprivation therapy alone. In a correlative study presented at the 2020 Genitourinary Cancers Sumposium, investigators also determined that the basal tumor subtype did not experience as much of a survival benefit with the addition of docetaxel to androgen deprivation therapy.

The FDA has accepted a Biologics License Application for MYL-1402O, a proposed biosimilar to bevacizumab, according to a press release from co-developers Biocon and Mylan. The BLA is seeking approval for the biosimilar as a treatment for multiple types of cancer and the FDA has set an action date goal of December 27, 2020, for a decision on the BLA.