ADCs in the pipeline: FDA spells out clinical pharmacology musts for sponsors
The market for antibody drug conjugates, or ADCs, is heating up, and the FDA on Monday sought to offer some guidance based on its past experience with ADC development programs in oncology by offering new draft guidance on clinical pharmacology considerations for ADCs in particular.
So far, 12 ADCs for various cancer targets have won FDA approval, with some heavy-hitters coming to market more recently, like Roche’s Kadcyla, which has already reached blockbuster status. Other companies like Seagen have become leaders in ADC development, with 8 ADCs in their pipeline, while others like J&J laid some sizeable recent bets on ADCs moving forward.
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