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Based on the phase II study BLC2001, erdafitinib has been granted a breakthrough therapy designation by the FDA for the treatment of metastatic urothelial carcinoma, according to Janssen, the manufacturer of the oral pan-FGFR tyrosine kinase inhibitor.

<em>Targeted Therapies in Oncology</em>, an oncology resource that provides oncology professionals with cutting-edge research, data, and treatment strategies surrounding molecular and immune system targets, welcomes Arjun V. Balar, MD, as its editor-in-chief.

Bridget F. Koontz, MD, associate professor of radiation oncology, Duke Cancer Institute, discusses a single-arm, phase II trial of 6 months of concurrent androgen deprivation therapy/abiraterone acetate (Zytiga) plus prednisone and definitive radiotherapy for men with intermediate- to high-risk localized prostate cancer.

A supplemental new drug application for Blue Light Cytoscopy with Cysview, a procedure for detecting bladder cancer, was recently approved by the FDA.










Lung Cancer

Based on results of the phase III SPARTAN trial, apalutamide has been approved by the FDA for the treatment of patients with nonmetastatic castration-resistant prostate cancer, making it the first treatment to be approved in this setting.<br />

According to results of the randomized phase II CABOSUN trial,<span style="font-size:10.8333px"> </span>PFS was improved with sunitinib as initial systemic therapy across subgroups of patients with intermediate- and poor-risk advanced renal cell carcinoma. The advantage to cabozantinib on PFS was particularly strong in patients who were MET-positive.

Updated findings from the phase III KEYNOTE-045 trial confirmed the benefit of pembrolizumab (Keytruda) compared with chemotherapy in pretreated patients with locally advanced or recurrent urothelial cancer. Two-year follow-up of the trial presented at the 2018 Genitourinary Cancers Symposium demonstrated that overall survival was improved with pembrolizumab.

Results from a phase II study presented at the 2018 Genitourinary Cancers Symposium, demonstrated that durvalumab, a PD-L1 inhibitor, had synergy in combination with the PARP inhibitor olaparib in unselected men with metastatic castration-resistant prostate cancer.

In findings from the STAMPEDE trial, a trial that has enrolled more than 9000 men with M0 and M1 prostate cancer since 2005, the addition of docetaxel (Taxotere) to frontline long-term hormone therapy improved quality of life and reduced the need for subsequent therapy in patients with advanced prostate cancer. This has led to lower overall costs in the nonmestatic setting.

During the 2018 Genitourinary Cancers Symposium, Monika Joshi, MD, assistant professor, Penn State Hershey Medical Center, shared results of a phase Ib study of durvalumab (Imfinzi) and radiation therapy (DUART) followed by adjuvant durvalumab in patients with bladder cancer.

In findings from the phase III SPARTAN trial presented at the 2018 Genitourinary Cancers Symposium and published in the <em>New England Journal of Medicine, </em>apalutamide (Erleada) reduced the risk of metastasis or death by 72% in patients with nonmetastatic castration-resistant prostate cancer.



















































