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New Drugs and Novel Indications for Genitourinary Cancers, FDA Approved 2017–2019


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May 14, 2019: Avelumab (Bavencio) plus axitinib (Inlyta) for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

April 19, 2019: Pembrolizumab (Keytruda) plus axitinib (Inlyta) for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

April 12, 2019: Erdafitinib (ASG-22ME) for patients with locally advanced or metastatic urothelial carcinoma, with susceptible FGFR3 or FGFR2 genetic alterations, that has progressed during or following platinum-containing chemotherapy. 

August 16, 2018: Prescribing information for pembrolizumab and atezolizumab (Tecentriq) updated to require the use of an FDA-approved companion diagnostic test to determine PD-L1 levels in tumor tissue from patients with locally advanced or metastatic urothelial cancer who are cisplatin-ineligible.

July 13, 2018: Enzalutamide (Xtandi) approved for patients with castration-resistant prostate cancer.

June 19, 2018:  Use of atezolizumab and pembrolizumab limited to patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing therapy.

April 16, 2018: Nivolumab (Opdivo) and ipilimumab (Yervoy) in combination approved for the treatment of intermediate- or poor-risk previously untreated advanced renal cell carcinoma. 

February 14, 2018: Apalutamide (Erleada) approved for nonmetastatic castration-resistant prostate cancer. 

February 7, 2018: Abiraterone acetate (Zytiga) tablets approved in combination with prednisone for metastatic high-risk castration-sensitive prostate cancer.

December 19, 2017: Cabozantinib (Cabometyx) approved for treatment of patients with advanced renal cell carcinoma.

November 16, 2017: Sunitinib malate (Sutent) approved for the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma following nephrectomy. 

September 14, 2017: A lower dose of cabazitaxel (20 mg/m2 every 3 weeks) approved in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen. Cabazitaxel at a dose of 25 mg/m2 every  3 weeks was approved for this indication in 2010.  

May 9, 2017: Avelumab (Bavencio) approved for previously treated, locally advanced or metastatic urothelial carcinoma. 

May 1, 2017: Durvalumab (Imfinzi) received accelerated approval for the treatment of previously treated, locally advanced or metastatic urothelial carcinoma.  

February 2, 2017: Nivolumab approved for treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with a platinum-containing chemotherapy. ■


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