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Regulators should refuse to approve a two-drug combination unless there is evidence that both drugs are doing something, so patients are not exposed to useless extra toxicity and cost.
Several combinations (for example anti-TIGIT plus PD-L1, IDO inhibitor plus PD-1) reached phase 3 without randomised evidence of the added agent's contribution and failed. FDA guidance on co-development already asks for contribution-of-components data but allows exceptions. Making a randomised contribution assessment (or a factorial design) a firm condition of accelerated approval for combinations would redirect development effort towards combinations with evidence of synergy.
Shares Combination Cancer Therapy Can Confer Benefit via Patient-to-Patient Variability without Drug Additivity or Synergy, Too many combinations to test.
Shares Combination Cancer Therapy Can Confer Benefit via Patient-to-Patient Variability without Drug Additivity or Synergy, Too many combinations to test.
Shares Combination Cancer Therapy Can Confer Benefit via Patient-to-Patient Variability without Drug Additivity or Synergy, Too many combinations to test.
Shares Accelerated approval, Incentives reward me-too drugs and marginal gains.
Shares Combination Cancer Therapy Can Confer Benefit via Patient-to-Patient Variability without Drug Additivity or Synergy, Too many combinations to test.
Shares Combination Cancer Therapy Can Confer Benefit via Patient-to-Patient Variability without Drug Additivity or Synergy, Too many combinations to test.
Shares Combination Cancer Therapy Can Confer Benefit via Patient-to-Patient Variability without Drug Additivity or Synergy, Too many combinations to test.
Shares Combination Cancer Therapy Can Confer Benefit via Patient-to-Patient Variability without Drug Additivity or Synergy, Too many combinations to test.