An FDA advisory panel on Tuesday voted against recommending approval of Bristol-Myers Squibb and AstraZeneca’s dapagliflozin for adults with type 2 diabetes due to concerns about a potential risk of breast and bladder cancer. The FDA is expected to issue a final decision on approval of the drug by October 28.
Panel members voted 9-6 against a question that asked if the efficacy and safety data submitted in support of the drug provided substantial evidence to support approval. Specifically, panelists expressed concern about the drug’s cancer, liver and kidney risks, especially among elderly patients. Panel members who voted in support of dapagliflozin said they were also concerned about the potential safety implications, but said that more information on those risks could only be discovered in large patient registries and post-marketing studies that could be established following approval of the compound.