The FDA’s Breakthrough Therapy Designation is intended to expedite the development and review of drugs that show early signs of potential clinical benefit in serious diseases to provide patients with access to new therapies as soon as possible.
Bristol-Myers Squibb shared results from a Phase 2 study as well as other supportive data surrounding Opdivo in its request for the designation.
The company hopes to file a market application for the drug in several months, according to Jean Viallet, MD, global clinical research lead of oncology at Bristol-Myers Squibb.
The FDA previously granted Breakthrough Therapy Designations of Opdivo for a variety of indications, including previously treated melanoma and non-squamous, non-small cell lung cancer.
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