Plate 09 — Routes
What is genuinely still possible, what each route requires, and where each one stops.
This section is information, not advertising. It describes routes that exist, names no provider, recommends no treatment and promises no outcome. Nothing here replaces a conversation with a doctor.
Before anything else
00
Treating physician — the precondition for everything below
What it takes
An oncologist willing to look past the standard protocol. This is the hardest step, and the one people skip.
Where it stops
Without one, none of the routes below exist. Not a single one can be started by a patient alone — trials enrol through an investigator, expanded access is filed by a physician, off-label is an act of prescribing.
Then, roughly in the order a tumour board would consider them
01
Comprehensive molecular profiling
What it takes
Tissue from a biopsy or an earlier operation. Increasingly reimbursed — ask before assuming it is not.
Where it stops
A large share of profiles show nothing currently actionable. That is a normal result rather than a failed test.
02
Molecular tumour board
What it takes
A centre that runs one. This is where certification matters — see the centres directory.
Where it stops
The board can only work with what the profile shows. It cannot create a target that is not there.
03
Biomarker-matched clinical trial
What it takes
Eligibility, a site within reach, an open slot. The investigator enrols — but you can contact the site yourself.
Where it stops
Eligibility is written as prose and is stricter than it reads. Prior lines of therapy exclude more people than the biomarker does.
04
Individualised neoantigen therapy
What it takes
Enrolment in a trial — it is not available outside one. The tumour is sequenced, then a bespoke product is made for it.
Where it stops
Trials run mainly in melanoma and mainly after surgery. For advanced disease or another tumour type there may be no arm at all.
05
Off-label prescribing, structured through TAPUR
What it takes
A prescriber, and for TAPUR a matching molecular alteration. ASCO supplies the drugs free within that study.
Where it stops
Outside a study the payer decides. Coverage is the practical wall here, not the law.
06
Expanded access, also called compassionate use
What it takes
Your physician files it and becomes responsible for it. The manufacturer has to agree to supply first — that agreement is the real gate.
Where it stops
The manufacturer can simply decline, and often does. The regulator is not the obstacle here.
07
N-of-1 therapeutic development
What it takes
An academic lab willing to take it on, and money. Regulators now publish guidance for individualised applications, so the path exists on paper.
Where it stops
Nearly every attempt stops here. It needs a laboratory that says yes, safety testing, and someone to manufacture it. Assume years, a six-figure sum, and that it does not happen.
Documented cases, and what each one actually took.
Figures
Expanded access: 692 of 692 single-patient oncology applications allowed to proceed, median processing time one day (FDA Project Facilitate). Individualised neoantigen therapy mRNA-4157/V940 with pembrolizumab: 49% lower risk of recurrence or death than pembrolizumab alone at five years — in resected, high-risk melanoma (KEYNOTE-942, phase 2b). That is an early-stage, post-surgical setting and not the situation this page describes. N-of-1 development: ten months from diagnosis to first dose in the milasen case (NEJM 2019) — Batten disease, not cancer.