FDA Approves Atezolizumab for Advanced Urothelial Carcinoma
The FDA has granted accelerated approval to atezolizumab (Tecentriq) for the treatment of locally advanced or metastatic urothelial carcinoma.
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to atezolizumab (Tecentriq) for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have experienced disease progression during or after platinum-based chemotherapy, or whose disease has worsened within 12 months of receiving neoadjuvant or adjuvant platinum-based chemotherapy.1
“Even though bladder cancer is the 5th most commonly diagnosed cancer in the United States, it hasn't received the same attention within the cancer community as other common cancers,” said Diane Zipursky Quale, president and co-founder, Bladder Cancer Advocacy Network. “Tecentriq is a new medicine for people whose locally advanced or metastatic bladder cancer has progressed on platinum-based chemotherapy and may have limited treatment options.”
Accelerated approval was based on findings from the phase 2 IMvigor 210 trial, which evaluated the efficacy and safety of atezolizumab in 310 patients with locally advanced or metastatic urothelial carcinoma, regardless of PD-L1 expression. Participants received atezolizumab 1200 mg intravenously on day 1 of each 21-day cycle until disease progression or unacceptable toxicity.
Results showed that at a median follow-up of 14.4 months, 14.8% (95% CI, 11.1-19.3) of patients achieved a response overall, with 5.5% and 9.4% achieving complete and partial responses, respectively. Median duration of response has not yet been reached.
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Among 100 patients with a PD-L1 expression of 5% or greater in tumor-infiltrating immune cells, 26.0% (95% CI, 17.7-35.7) achieved a response, while 9.5% of the 210 patients with expression less than 5% had a response.
The most common adverse events were fatigue, decreased appetite, nausea, urinary tract infection, pyrexia, and constipation. Ten of the 310 patients discontinued therapy due to adverse reactions.
- FDA grants Genentech's cancer immunotherapy Tecentriq™ (atezolizumab) accelerated approval for people with a specific type of advanced bladder cancer [news release]. South San Francisco, CA: Genentech; May 18, 2016. http://www.gene.com/media/press-releases/14626/2016-05-18/fda-grants-genentechs-cancer-immunothera. Accessed May 18, 2016.