Dapagliflozin Cancer Signal Weighs Heavily In FDA Panel's Negative Vote
This article was originally published in The Pink Sheet Daily
The Endocrinologic and Metabolic Drugs Advisory Committee votes 9-6 against approval of the first-in-class SGLT-2 inhibitor, with panelists citing the need for more pre-approval data on the risk of bladder and breast cancer with the diabetes drug.
You may also be interested in...
Dapagliflozin’s Commercial Appeal Could Dim With Bladder Cancer Concerns
Lingering questions surrounding an imbalance in bladder cancer cases – and how FDA decides to handle the issue in labeling – could threaten the diabetes drug’s uptake, particularly given the absence of a similar signal for J&J’s competing SGLT-2 inhibitor Invokana, already on the market.
Dapagliflozin Passes CV Safety Test For Now; FDA Panel Eyes Outcomes Study
Members of the Endocrinologic and Metabolic Drugs Advisory Committee endorse approval of Bristol/AstraZeneca’s SGLT-2 inhibitor, believing that the ongoing 17,000-patient DECLARE trial will supply needed answers around cardiovascular and bladder cancer concerns.
Dapagliflozin Gains Strong FDA Panel Endorsement The Second Time Around
In 13-1 vote, advisory committee backs Bristol/AstraZeneca’s SGLT-2 inhibitor for type 2 diabetes, saying that residual concerns about cardiovascular safety and bladder cancer will be clarified with planned and ongoing post-marketing studies; approval recommendation follows a negative panel vote in 2011.