# Every approved cancer drug ships with a public combination-readiness data pack

Source: https://onco.cc/ideas/idea-tr2-combo-readiness-dossier/  
OnCo record `idea-tr2-combo-readiness-dossier` (Idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Require that approved cancer drugs come with a standard set of data (blood levels, drug interactions, toxicity profile) so anyone can design a safe combination trial without asking the company.

## Summary

Combination trial designers need pharmacokinetic profiles, metabolic pathways, QT effects, myelosuppression kinetics and immunogenicity data that sit in confidential regulatory dossiers. A standardised, machine-readable 'combination-readiness' annex published at approval would let academics and other companies design combination studies and predict overlapping toxicity without bilateral negotiation.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- Hypothesis: Publication of readiness packs increases the number of investigator-initiated combination trials involving newly approved drugs by at least 30% within three years.
- Rationale: Open pharmacology data (as in the FDA labels' clinical pharmacology sections, but structured and complete) removes an information asymmetry that currently forces every combination through the originator.
- Proposed test: Pilot voluntary packs for ten recently approved oncology drugs and count investigator-initiated combination trials registered within two years compared with matched drugs without packs.
- Maturity: speculative
- Actor: regulator

## Sources

- Bottleneck evidence (Too many combinations to test): Palmer & Sorger, Combination cancer therapy can confer benefit via patient-to-patient variability without drug additivity or synergy (Cell 2017): https://doi.org/10.1016/j.cell.2017.11.009

## Connected records

- collections: [DrugBank & ChEMBL](https://onco.cc/collections/drugbank-chembl/), [FDA Oncology Approvals (OCE) & Novel Drug Approvals](https://onco.cc/collections/fda-approvals/)
- ideas: [A standard cross-company combination agreement that takes weeks, not years, to sign](https://onco.cc/ideas/idea-tr2-combination-template-agreement/)
- bottlenecks: [Secrecy and intellectual property block collaboration](https://onco.cc/bottlenecks/b-ip-collaboration/), [Too many combinations to test](https://onco.cc/bottlenecks/b-combination-space/)
- key papers: [Combination Cancer Therapy Can Confer Benefit via Patient-to-Patient Variability without Drug Additivity or Synergy](https://onco.cc/key-papers/paper-palmer-cell/)

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