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.
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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.
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.
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.