Bristol-Myers Squibb’s Opdivo gets US FDA breakthrough therapy designation for advanced bladder cancer
pharmafile | June 28, 2016 | News story | Manufacturing and Production, Research and Development, Sales and Marketing | Breakthrough Therapy Designation, Bristol-Myers Squibb, FDA, bladder cancer, opdivo, regulation
Bristol-Myers Squibb (NYSE:BMY) said the US Food and Drug Administration (FDA) has granted breakthrough therapy designation to its immunotherapy Opdivo for the potential indication in advanced bladder cancer.
As part of the breakthrough therapy designation submission, the company shared for the FDA’s review results from Phase II study CA209-275 and other supportive data investigating Opdivo in these previously treated bladder cancer patients.
Jean Viallet, global clinical research lead, oncology, Bristol-Myers Squibb, said: “Urothelial cancer is a common type of bladder cancer where patients experience high rates of recurrence and remains an area where new treatment approaches are needed, further underscoring the importance of this designation for Opdivo,. As part of our commitment to bring Opdivo to these advanced bladder cancer patients as quickly as possible, we look forward to filing a marketing application with health authorities based on results from study -275 and other supporting data in the coming months, as well as submitting the data for presentation at an upcoming medical meeting.”
The breakthrough therapy designation is an FDA program intended to expedite the development and review of medicines with early signals of potential clinical benefit in serious diseases to help ensure patients have access to new therapies as soon as possible.
Bladder cancer, which typically begins in the cells that line the inside of the bladder, is the ninth most commonly diagnosed cancer in the world, with an estimated 430,000 new cases diagnosed per year and over 165,000 deaths per year.
Opdivo is already approved in six indications.
Anjali Shukla
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