Atezolizumab Approved for Locally Advanced or Metastatic Urothelial Carcinoma
US Food and Drug Administration
The US Food and Drug Administration (FDA) granted accelerated approval to atezolizumab (TECENTRIQ), indicated for the treatment of locally advanced or metastatic urothelial carcinoma (mUC) in patients whose disease progresses during or following platinum-based chemotherapy, or whose disease worsened within 12 months of receiving platinum-based chemotherapy before or after surgery. Urothelial carcinoma accounts for 90% of all bladder cancers and can also be found in the renal pelvis, ureter, and urethra.
"Even though bladder cancer is the fifth 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.
Atezolizumab is a monoclonal antibody designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, atezolizumab may enable the activation of T cells. Atezolizumab may also affect normal cells.
The FDA's Accelerated Approval Program allows conditional approval of a medicine that fills an unmet medical need for a serious condition, based on early evidence suggesting clinical benefit. The indication for atezolizumab is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. The approval of atezolizumab is based on the Phase II IMvigor 210 study. Atezolizumab will be available in the United States within 1 to 2 weeks.
The phase 2 IMvigor 210 study is an open-label, multicenter, 2-cohort study that evaluated the safety and efficacy of atezolizumab in 310 people with locally advanced or metastatic urothelial carcinoma. The overall response rate was 14.8%, and patients with PD-L1 expression in 5% or more of their tumor-infiltrating immune cells had overall response rates of 26%, while those with lower levels of PD-L1 expression had overall response rates of 9.5%.
Potential adverse effects with atezolizumab include, but are not limited to, pneumonitis, hepatitis, colitis, hormone gland problems (especially the pituitary, thyroid, and adrenal glands and pancreas), neuropathy and meningoencephalitis, eye problems, severe infections, and severe infusion reactions.
Atezolizumab is also being evaluated in a confirmatory phase 3 study that compares atezolizumab to chemotherapy in people whose bladder cancer has progressed on at least one prior platinum-containing regimen.
1. 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.