FDA To Speed Up Review Of Roche Tecentriq As Immunotherapy Treatment For Bladder Cancer


Swiss pharmaceutical company Roche has announced that U.S. health regulators have agreed to grant priority review to its Tecentriq immunotherapy treatment for a type of bladder cancer.

In a statement, the drug company said that the U.S. Food and Drug Administration has accepted its Biologics License Application, or BLA, and agreed to priority-review the treatment.


Tecentriq (atezolizumab) was granted approval in May last year as treatment for people with the most common type of bladder cancer, urothelial carcinoma. It was the first treatment green-lighted for the condition in more than 30 years.

On Monday, Jan. 9, Roche revealed the FDA's recent decision that could speed up the approval of Tecentriq "for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who are ineligible for cisplatin chemotherapy, and are either previously untreated (first-line) or have disease progression at least 12 months after receiving chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant)."

Under the accelerated review, the FDA will make a decision within a period of six months whether or not to green-light Roche's application for use of Tecentriq in this particular group of patients. The FDA's new decision can boost the company's bid to expand the indication of its immunotherapy treatment.

Among Tecentriq's common side effects are decreased appetite, fatigue, nausea, fever, constipation, and urinary tract infection. The treatment also has potential to cause serious side effects and infection as a result of immune-mediated side effects.

Bladder Cancer

The American Cancer Society estimates that more than 79,000 Americans will be diagnosed with bladder cancer this year. Of these new diagnoses, about 11 percent will already be in advanced stages.

Survival Rates Based On Stage Of Disease During Diagnosis

Notably, there is dramatic difference in the survival rates between those whose bladder cancer was detected at an early stage and those who were diagnosed at an advanced stage.

About 96 percent of people diagnosed with the earliest stage of the disease will live at least five years. Only 39 percent of those diagnosed in advanced stages of the disease would survive that long. Men are between three to four times more likely to suffer from bladder cancer than women.

Metastatic Urothelial Cancer

Urothelial carcinoma comprises about 90 percent of all bladder cancer and can also be present in the ureter, urethra, and renal pelvis.

"Urothelial cells also line other parts of the urinary tract, such as the part of the kidney that connects to the ureter (called the renal pelvis), the ureters, and the urethra," the ACS explained on its website. "Patients with bladder cancer sometimes have other tumors in these places, so the entire urinary tract needs to be checked for tumors."

Metastatic urothelial cancer has limited treatment options. The disease, the ninth most common cancer worldwide, has not seen major advances for more than three decades.

In 2012, there were 430,000 new cases of the illness. It causes 145,000 global deaths per year. The disease is three times more prevalent in developed countries than in less developed nations.

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