FDA approval summary: Atezolizumab for the treatment of patients with progressive advanced urothelial carcinoma after platinum-containing chemotherapy

Oncologist

Volumn 22, Issue 6, 2017, Pages 743-748

  Ning, Yang Min ^a   Suzman, Daniel ^a   Maher, V Ellen ^a   Zhang, Lijun ^a   Tang, Shenghui ^a   Ricks, Tiffany ^a   Palmby, Todd ^a   Fu, Wentao ^a   Liu, Qi ^a   Goldberg, Kirsten B ^a   Kim, Geoffrey ^a   Pazdur, Richard ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Atezolizumab; Bladder cancer; Immunotherapy; Locally advanced or metastatic urothelial carcinoma; Platinum containing chemotherapy

Indexed keywords

ALANINE AMINOTRANSFERASE; ALKALINE PHOSPHATASE; ASPARTATE AMINOTRANSFERASE; ATEZOLIZUMAB; CARBOPLATIN; CISPLATIN; PLATINUM; PREDNISOLONE; PROGRAMMED DEATH 1 LIGAND 1; MONOCLONAL ANTIBODY;

ABDOMINAL PAIN; ADJUVANT CHEMOTHERAPY; AGED; ANEMIA; ARTICLE; BACKACHE; CANCER INFILTRATION; CLINICAL OUTCOME; COLITIS; CONSTIPATION; CREATININE CLEARANCE; DIABETES MELLITUS; DIARRHEA; DISEASE COURSE; DRUG EFFICACY; DRUG MEGADOSE; DRUG SAFETY; DRUG WITHDRAWAL; DYSPNEA; FATIGUE; FEMALE; FEVER; FOOD AND DRUG ADMINISTRATION; HEMATURIA; HEPATITIS; HUMAN; HYPERSENSITIVITY; HYPOALBUMINEMIA; HYPONATREMIA; HYPOTHYROIDISM; IMMUNOTHERAPY; INTESTINE OBSTRUCTION; LOSS OF APPETITE; LYMPH NODE METASTASIS; LYMPHOCYTOPENIA; MAJOR CLINICAL STUDY; MALE; NAUSEA; NECK PAIN; OPEN STUDY; OSTEOMYELITIS; PNEUMONIA; PRIORITY JOURNAL; PROTEIN EXPRESSION; RASH; RISK MANAGEMENT; SEPSIS; SIDE EFFECT; SKIN INFECTION; THYROID FUNCTION; THYROIDITIS; TRANSITIONAL CELL CARCINOMA; TREATMENT DURATION; URINARY TRACT INFECTION; VISCERAL METASTASIS; ADULT; DRUG APPROVAL; DRUG EFFECTS; MIDDLE AGED; PATHOLOGY; RESPONSE EVALUATION CRITERIA IN SOLID TUMORS; RISK ASSESSMENT; TREATMENT OUTCOME; UNITED STATES; URINARY TRACT TUMOR; UROTHELIUM;

ADULT; AGED; ANTIBODIES, MONOCLONAL; CARCINOMA, TRANSITIONAL CELL; DRUG APPROVAL; FEMALE; HUMANS; MALE; MIDDLE AGED; PLATINUM; RESPONSE EVALUATION CRITERIA IN SOLID TUMORS; RISK ASSESSMENT; TREATMENT OUTCOME; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; UROLOGIC NEOPLASMS; UROTHELIUM;

EID: 85020854314     PISSN: 10837159     EISSN: 1549490X     Source Type: Journal    
DOI: 10.1634/theoncologist.2017-0087     Document Type: Article

References (19)

1. Siegel RL, Miller KD, Jemal A. Cancer Statistics, 2016. CA Cancer J Clin 2016;66:7-30.
2. National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology: Bladder cancer, version I. 2016; NCCN.org 3.
3. Park JC, Citrin DE, Agarwal PK et al. Mutimodal management of muscle invasive bladder cancer. Curr Probl Cancer 2014;38:80-108.
4. Bellmunt J, Theodore C, Demkov T et al. Phase III trial of vinflunine plus best supportive care compared with best supportive care alone after a platinum-containing regimen in patients with advanced transitional cell carcinoma of the urothelial tract. J Clin Oncol 2009;27:4454-4461.
5. Sweeney CJ, Roth BJ, Kabbinavar FF et al. Phase II study of pemetrexed for second-line treatment of transitional cell cancer of the urothelium. J Clin Oncol 2006;24:3451-7.
6. Choueiri TK, Ross RW, Jacobus S et al. Doubleblind, randomized trial of docetaxel plus vandetanib versus docetaxel plus placebo in platinumpretreated metastatic urothelial cancer. J Clin Oncol 2011;30:507-512.
7. Ko YJ, Canil CM, Mukherjee SD et al. Nanoparticle albumin-bound paclitaxel for second-line treatment of metastatic urothelial carcinoma: A single group, multicentre, phase 2 study. Lancet Oncol 2013;14: 769-76.
8. Petrylak DP, Tagawa ST, Kohli M, et al. Docetaxel as monotherapy or combined with ramucirumab or icrucumab in second-line treatment for locally advanced or metastatic urothelial carcinoma: An open-label, three-arm, randomized controlled Phase II trial. J Clin Oncol 2016;34:1500-1509.
9. Cha E, Wallin J, and Kowanetz M. PD-L1 inhibition with MPDL3280A for solid tumors. Semin Oncol 2015;42:484-487.
10. Powles T, Eder JP, Fine GD et al. MPDL3280A (anti-PD-L1) treatment leads to clinical activity in metastatic bladder cancer. Nature 2014;515:558-562.
11. FDA Clinical and Statistical Reviews of Atezolizumab for Second-line Use in Advanced Urothelial Carcinoma Available at: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761034Orig1s000MedR.pdf. Accessed December 1, 2016.
12. Rosenberg JE, Hoffman-Censits J, Powles T et al. Atezolizumab in patients with locally advanced and metastatic urothelial carcinoma who have progressed following treatment with platinum-based chemotherapy: a single-arm, multicenter, phase 2 trial. Lancet 2016;387:1909-1920.
13. Johnson JR, Ning YM, Farrell A et al. Accelerated approval of oncology products: The food and drug administration experience. J Natl Cancer Inst 2011;103:636-644.
14. Bellmunt J, Mullane SA, Werner L et al. Association of PD-L1 expression on tumorinfiltrating mononuclear cells and overall survival in patients with urothelial carcinoma. Ann Oncol 2015;26: 812-817.
15. Apolo AB, Infante JR, Hamid O, et al. Avelumab (MSB0010718C; anti-PD-L1) in patients with metastatic urothelial carcinoma from the JAVELIN solid tumor phase 1b trial: Analysis of safety, clinical activity, and PD-L1 expression. J Clin Oncol 2016;34 (suppl; abstr 4514).
16. Massard C, Gordon MS, Sharma S et al. Safety and efficacy of durvalumab (MEDI4736), an anti-programmed cell death ligand-1 immune checkpoint inhibitor, in patients with advanced urothelial bladder cancer. J Clin Oncol 2016;34:3119-125.
17. Elizabeth R. Plimack, Joaquim Bellmunt, Shilpa Gupta, et al. Pembrolizumab (MK-3475) for advanced urothelial cancer: Updated results and biomarker analysis from KEYNOTE-012. J Clin Oncol 2015;33 (suppl; abstr 4502).
18. Sharma P, Bono P, Kim JW et al: Efficacy and safety of nivolumab monotherapy in metastatic urothelial cancer (mUC): Results from the phase I/II CheckMate 032 study. J Clin Oncol 2016;34 (suppl; abstr 4501).
19. Bellmunt J, de Wit R, Vaughn DJ et al:KEYNOTE-045: Open-label, phase III study of pembrolizumab versus investigator’s choice of paclitaxel, docetaxel, or vinflunine for previously treated advanced urothelial carcinoma. http://jitc.biomedcentral.com/articles/10.1186/s40425-016-0191-4. Accessed December 2016.