The U.S. Food and Drug Administration (FDA) approved Wednesday a new drug to treat urothelial carcinoma, a prevalent type of bladder cancer. This is the first medication of its kind to be sold in the country, for patients with metastatic urothelial carcinoma. This disease affects more than 70,000 people in the U.S. every year.
Tecentriq (atezolizumab) is a PD-1/PD-L1 inhibitor developed by Roche Holding AG. It attacks proteins located on the “body’s immune cells and some cancer cells,” said the FDA. It stimulates the body’s immune system to fight cancer cells.
The medicine was specifically approved for patients with locally advanced or metastatic urothelial carcinoma, whose cancer has deteriorated after receiving platinum-containing chemotherapy. Urothelial carcinoma is responsible for 90 percent of all bladder cancer.
Patients whose disease has aggravated after receiving 12 months of platinum-containing chemotherapy, also qualify for Tecentriq treatment. Effects of the drug were studied in 310 patients, who had locally advanced or metastatic urothelial carcinoma, said the FDA.
“Tecentriq 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,” said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development.
Horning said in a statement that Roche was thankful to doctors, patients and family members, who participated in trials to use Tecentriq as a treatment for advanced urothelial carcinoma.
Impact of bladder cancer in the U.S.
The American Cancer Society (ACS) calculates that nearly 77,000 Americans will be diagnosed with bladder cancer in 2016. About 11 percent of all new diagnosed are conducted when the disease is in advanced stages. It is the fourth most common cancer in men.
Bladder cancer majorly affects elderly adults. 9 out of 10 people with this disease are over 55 years old. “The average age at the time of diagnosis is 73”, said the ACS. There will be an estimated 16,390 deaths from bladder cancer in the nation, within 2016.
Metastatic urothelial cancer is associated with limited treatment options. It has seen no major advances for 30+ years. #bladdercancer
— Roche (@Roche) May 19, 2016
Nearly 15 percent of patients who received Tecentriq showed tumor shrinkage
A study carried out by Roche analyzed if patients who received Tecentriq showed shrinkage of their tumors. From all 310 participants of the study, 14.8 percent “had partial shrinkage.” Common side effects of the drug include fatigue, decreased appetite, nausea and constipation, said the FDA.
It can also trigger infection and “serious side effects” on healthy organs such as the lung, colon and endocrine system, added the FDA. Roche is currently comparing the effects of the new drug to chemotherapy, in patients “whose bladder cancer has progressed on at least one prior platinum-containing regimen.”
“Products that block PD-1/PD-L1 interactions are part of an evolving story about the relationship between the body’s immune system and its interaction with cancer cells,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.
The stock price of Roche Holding AG (VTX: ROG) surged 2.40 percent on Friday by 4:36 PM GMT+2, in the context of the FDA announcement.
— Roche (@Roche) May 19, 2016
Source: FDA (Press Release)