No accelerated approval for a combination without proof each part contributes
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.
- Too many combinations to test · There are thousands of possible drug pairs and sequences. Trials can test a few dozen a year.
- Incentives reward me-too drugs and marginal gains · The system pays the same for a drug that adds two months as for a cure, so companies race to copy rather than to cure.
Pages like this
not linked directly; found by shared links- IdeaSponsors deposit the confirmatory trial budget in escrow at accelerated approval
Shares Accelerated approval, Incentives reward me-too drugs and marginal gains.
- TargetTIGIT
- IdeaConditional approvals that lapse automatically if the confirmatory trial is late
Shares Accelerated approval, Incentives reward me-too drugs and marginal gains.
- IdeaTransferable priority vouchers for first-in-class drugs, with price conditions
Shares Accelerated approval, Incentives reward me-too drugs and marginal gains.
- IdeaPatent term extension scaled to proven survival gain
Shares Accelerated approval, Incentives reward me-too drugs and marginal gains.
- Key paperBREAKWATER: encorafenib plus cetuximab with chemotherapy as first treatment for BRAF V600E-mutated colorectal cancer