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. ■
