FDA Speeds Up Review Of Roche's Immunotherapy Drug Tecentriq For Bladder Cancer
The U.S. Food and Drug Administration (FDA) agreed to provide a priority review of Roche's Tecentriq, an immunotherapy drug for another type of bladder cancer.
The swiss pharmaceutical company said that health regulators have accepted its Biologics License Application or BLA and agreed to priority-review the treatment.
Under the accelerated review, FDA will make a decision within six months on Roche's application for the treatment's use in patients with metastatic urothelial carcinoma who are ineligible for cisplatin chemotherapy, Fox News reports.
"In May 2016, TECENTRIQ became the first treatment approved by the FDA for people with previously treated advanced bladder cancer in more than 30 years," Dr. Sandra Horning, Chief Medical Officer and Head of Global Product Development, said in a press release.
"We are committed to continuing working with the FDA to make TECENTRIQ available to more people with this type of advanced bladder cancer, specifically those who are unable to tolerate cisplatin-based chemotherapy as an initial treatment," she added.
What Is Tecentriq?
On January 2017, FDA has granted Tecentriq (atezolizumab) as a cancer immunotherapy drug. It has been evaluated as the first-line treatment option for people not eligible for cisplatin chemotherapy.
The drug is also intended for people who are either previously untreated or have disease progression at least 12 months after receiving chemotherapy. It was also approved last year for patients with non-small cell lung cancer, the most common form of lung cancer.
Metastatic Urothelial Carcinoma
Urothelial carcinoma is by far the most common type of bladder cancer. It's the 9th most common cancer across the globe and an estimated 165,000 people die from this disease every year, including about 15,000 Americans in 2015, the Cleveland Clinic reports.
However, there have been no major advances in the treatment of this type of cancer since platinum-based chemotherapy has been developed about 30 years ago. The survival rate in previously untreated patients with metastatic urothelial cancer who received chemoltherapy is about 15 months. Prognosis for patients with relapse is grim, with a survival of 5 to 7 months.