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FDA recently granted accelerated approval for atezolizumab (Tecentriq, Genentech), the first drug for bladder cancer that utilizes the body’s immune system. The drug will be available by early June.
FDA recently granted accelerated approval for atezolizumab (Tecentriq, Genentech), the first drug for bladder cancer that utilizes the bodyâs immune system. The drug will be available by early June.
Tecentriq is indicated for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-based chemotherapy, or whose disease has worsened within 12 months of receiving platinum-based chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant).
âTecentriq is a new medicine that can work with the immune system to treat people with a type of bladder cancer that progressed after platinum-based chemotherapy,â said Sandra Horning, MD, chief medical officer and head of Global Product Development.
Urothelial carcinoma accounts for 90% of all bladder cancers and can also be found in the renal pelvis, ureter and urethra. FDAâs 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.
"Even though bladder cancer is the fifth most commonly diagnosed cancer in the United States, it hasnât received the same attention within the cancer community as other common cancers,â said Diane Zipursky Quale, president and co-founder, Bladder Cancer Advocacy Network.
FDAâs approval is based on the Phase II IMvigor 210 study. In a subset of people in the IMvigor 210 study with disease progression following neoadjuvant or adjuvant platinum-containing therapy, Tecentriq shrank tumors in 22% of people.
The most common Grade 3-4 adverse reactions during the study were: urinary tract infection (9%), anemia (8%), fatigue (6%), dehydration, intestinal obstruction (partial or complete blockage of the bowel), urinary obstruction, hematuria (blood in the urine; 3%), dyspnea (difficulty breathing; 4%), acute kidney injury, abdominal pain (pain in stomach area; 4%), venous thromboembolism (blood clots in the vein), sepsis (blood infection) and pneumonia (lung infection).
Three people (0.9%) experienced either sepsis, pneumonitis (lung problems) or intestinal obstruction, which led to death. Tecentriq was discontinued for adverse reactions in 3.2 % of the 310 patients.