Genitourinary Cancer

The FDA has approved olaparib (Lynparza) for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide (Xtandi) or abiraterone acetate (Zytiga).

The FDA approved single-agent rucaparib (Rubraca) for the treatment of patients with BRCA1/2-mutant, recurrent, metastatic castrate-resistant prostate cancer.

Olaparib (Lynparza) significantly improved overall survival (OS) versus abiraterone acetate (Zytiga) or enzalutamide (Xtandi) in patients with metastatic castration-resistant prostate cancer (mCRPC) harboring BRCA1/2 or ATM mutations, which are subsets of homologous recombination repair (HRR) gene mutations, according to updated findings from the phase III PROfound trial.

A New Drug Application (NDA) has been submitted to the FDA for single-agent relugolix for use as a treatment for men with advanced prostate cancer, according to Myovant Sciences, the developer of the oral GnRH receptor antagonist.

The FDA approved mitomycin gel (Jelmyto) for the treatment of patients with low-grade upper tract urothelial cancer (UTUC), cancer of the lining of the urinary system. This is the first therapy approved in this space.

The use of PARP inhibitors against DNA damage repair (DDR) alterations in prostate cancer is the first display of the potential for widespread precision medicine in the field, according to William K. Oh, MD, in a presentation during the 13th Annual Interdisciplinary Prostate Cancer Congress® and Other Genitourinary Malignancies.

The optimal sequencing of therapies for patients with metastatic castration-resistant prostate cancer (mCRPC) has proven to be a significant clinical challenge following the approvals of additional agents, said William K. Oh, MD.

Treatment options for patients with localized bladder cancer, beyond Bacillus Calmette-Guérin (BCG), are evolving as immunotherapies and novel agents are gaining traction in the management of this population, according to John P. Sfakianos, MD.

Biomarker-driven treatments continue to expand in prostate cancer, as research efforts explore responses across different subgroups, explained Petros Grivas MD, PhD.

The FDA has accepted a biologics license application for a proposed biosimilar for bevacizumab (Avastin), according to an announcement by Mylan during its fourth quarter 2019 earnings call.

The antidepressant phenelzine showed antitumor activity in patients with biochemical recurrent castrate-sensitive prostate cancer, according to a pilot study conducted by researchers at the University of Southern California (USC).

Preliminary durability results of the EV-103 study show that the combination of enfortumab vedotin and pembrolizumab may be a promising option for patients with locally advanced or metastatic urothelial carcinoma.

The addition of the off-the-shelf cancer immune primer ilixadencel to sunitinib (Sutent) trended toward a benefit in overall survival (OS) compared with sunitinib alone as a first-line treatment for patients with newly diagnosed metastatic renal cell carcinoma (RCC).

With the advent of targeted therapy, understanding the genetic components of a patient's disease has become critical in oncology. As the role of genetic testing in prostate cancer has grown, the field is also overcoming hurdles with making it more widespread, said Thomas J. Polascik, MD.

The FDA granted priority review to rucaparib for the treatment of adult patients with BRCA1/2-mutant recurrent, metastatic castration-resistant prostate cancer.

The standard of care for treatment-naïve patients with advanced renal cell carcinoma (RCC) has shifted from a single-agent VEGF TKI to a checkpoint inhibitor plus either a VEGF TKI or a CTLA-4 inhibitor, explained David F. McDermott, MD.

Novel next-generation imaging modalities have greater visibility than conventional imaging tools, leading to higher detection rates and earlier treatment of early recurrences and metastatic disease among men with prostate cancer, explained Hussein Aoun, MD.

The approval of several TKIs and combination regimens has led to more treatment options for patients with renal cell carcinoma (RCC), with a heavier focus on individualized approaches, explained Ajjai Shivaram Alva, MBBS.

The FDA approved pembrolizumab (Keytruda) for the treatment of patients who are unresponsive to Bacillus Calmette-Guerin (BCG) treatment with high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

There is still a lack of clear biomarkers in the metastatic renal cell carcinoma space.

Three pivotal trials demonstrating improved metastasis-free survival (MFS) with 3 different oral antiandrogen agents in combination with androgen deprivation therapy (ADT) have led to FDA approvals that have transformed the treatment paradigm in nonmetastatic castration-resistant prostate cancer (CRPC), said Elisabeth I. Heath, MD, FACP.

Within approximately 1 year, 3 combination regimens featuring immunotherapy agents were approved by the FDA for the frontline treatment of patients with metastatic renal cell carcinoma (RCC), said Robert J. Motzer, MD.

The FDA has approved a supplemental new drug application for enzalutamide (Xtandi) for the treatment of patients with metastatic castration-sensitive prostate cancer.

The FDA has approved 2 abbreviated new drug applications (ANDAs) for everolimus (Afinitor) tablets for the treatment of patients numerous malignancies.

While cytoreductive nephrectomy has been a mainstay in kidney cancer treatment, there are factors to consider before using the procedure on patients with the disease.

The FDA has granted a priority review designation to pembrolizumab (Keytruda) for the treatment of patients with Bacillus Calmette-Guerin (BCG)–unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in-situ (CIS) with or without papillary tumors who are ineligible for or chose to not undergo cystectomy.

Results from the phase III CARD trial suggest positive outcomes for patients with advanced prostate cancer on a novel treatment chemotherapy combination therapy treatment.

While the findings from the most recent CARD study prove promising, it's the toxicity results that have one expert excited.