Doctors do not approve a targeted cancer drug solely because a test found a mutation. They combine the tumour’s biomarker result with its origin, stage, current spread, previous treatment, the patient’s health, the drug’s evidence and approval status, and practical issues such as testing quality, cost and access. A biomarker match can support a treatment choice, but it cannot guarantee that the therapy will work.
What “targeted therapy” means
Targeted therapies are medicines designed to interfere with specific proteins or molecular processes that help cancer cells grow, divide or spread. The relevant feature may be a gene change, a protein made in unusually large amounts, a gene fusion or another measurable characteristic of the tumour. Biomarker testing looks for those features so the oncology team can decide whether a particular treatment is biologically plausible.
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This is different from inherited (germline) testing, which looks for changes present throughout the body and may indicate a hereditary cancer risk. A tumour biomarker test examines the cancer itself. The two tests can sometimes be ordered together, but they answer different clinical questions.
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A result is only one part of the decision. The same molecular finding can have different significance in different cancer types, stages or treatment lines. Conversely, a patient may be considered for a targeted treatment even when no single alteration explains the cancer, if the drug has evidence for another relevant marker or if a clinical trial is available.
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How the treatment decision is made
1. Define the clinical situation first
The team begins with the diagnosis rather than the laboratory report. Doctors establish where the cancer began, its histologic type, stage, sites of spread, current symptoms, growth rate and whether it has returned or progressed. They review operations, radiotherapy, chemotherapy, immunotherapy and any earlier targeted drugs.
General health also changes what is reasonable. Kidney and liver function, heart or lung disease, infections, other medicines, performance status and the patient’s goals can affect whether a drug is safe. NCI describes tumour type, size and spread as continuing factors in targeted-treatment selection alongside molecular findings.
2. Identify a treatment-relevant target
The oncologist asks whether the cancer carries a feature linked to a drug with credible evidence. Some cancers routinely require biomarker testing because a result can determine the first treatment; NCI specifically notes routine use in some people with non-small cell lung cancer, breast cancer and colorectal cancer. For advanced cancers, clinicians often suggest broader genomic profiling, but testing is not automatically useful for every diagnosis.
The question is not simply “Is there a mutation?” It is “What exact alteration is present, in which cancer, and is there a treatment that has demonstrated benefit in that setting?” A change can be actionable, associated with resistance, benign, or of unknown significance. A variant of unknown significance should not be used by itself to choose treatment.
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3. Select the assay and an adequate sample
Testing may measure genes, proteins or other markers. A laboratory can examine one biomarker with a focused assay or many genes and features with a larger panel. The appropriate test depends on the cancer and the clinical question; a broad panel is not automatically better than a focused test.
| Sample or approach | What it can offer | Important limitations |
|---|---|---|
| Tumour tissue | Material from a biopsy or surgery can be examined directly for DNA, RNA, proteins or other features. | A biopsy may be difficult or unsafe; the specimen can contain too little tumour or may no longer represent the cancer after treatment. |
| Blood-based liquid biopsy | Circulating tumour DNA can sometimes reveal alterations without another invasive biopsy, particularly when tissue is unavailable. | A negative blood result may reflect too little tumour DNA rather than absence of a target; the test’s approved uses and performance depend on the specific assay. |
| Single-marker assay | Answers a narrow question quickly when one established marker drives treatment selection. | It will not detect unrelated alterations that could matter later. |
| Multi-gene or genomic panel | Surveys many genes or other features and may identify trial or treatment options. | It can produce findings with uncertain significance and does not guarantee that a matched drug is available or effective. |
If obtaining tissue is unsafe or impossible, a liquid biopsy may be considered. The oncology team and laboratory must interpret what a negative, failed or low-level result means; a blood test is not an automatic substitute for tissue in every situation.
4. Read the report in context
The report should identify the alteration, the specimen and assay used, quality metrics, and how the laboratory classifies the finding. Clinicians then ask whether the result is:
- Predictive of sensitivity: associated with a higher chance of benefit from a particular drug.
- Predictive of resistance: a reason a treatment may be unlikely to work.
- Prognostic: related to expected disease behaviour, but not necessarily a guide to a specific medicine.
- Uncertain or benign: not a basis for selecting a treatment without stronger evidence.
A companion diagnostic is a test paired with a particular drug and indication to identify patients whose tumours have the relevant marker. Its label is specific to that test, medicine, cancer and use. A test lacking a companion-diagnostic label is not automatically useless, but the evidence and regulatory context require specialist interpretation. In an NCI report dated October 15, 2020, physician Park explained that absence of such a label meant the company had not completed approval for that particular drug, not necessarily that the finding could never be useful. NCI researcher Ana Robles, Ph.D., noted in the same report that companion-diagnostic labels covered only a limited number of genetic matches and that regulation had not fully caught up with the science. Those comments describe the regulatory landscape at that time, not a guarantee of benefit.
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5. Match the finding to evidence and access
Once a target is confirmed, the team determines what kind of option it represents:
| Potential route | What it means for the patient | Questions the team must answer |
|---|---|---|
| Approved indication | The medicine is authorised for this cancer and the patient’s biomarker or disease situation. | Does the approval cover this stage, treatment line and assay? What benefit and risks were shown? |
| Off-label use | The drug is licensed for another use but may have supporting evidence in this situation. | How strong and relevant is the evidence, and will insurance pay? |
| Clinical trial | The patient may receive an investigational or established treatment under a study protocol. | Are eligibility, location, timing, travel and trial risks acceptable? |
Evidence must match the patient’s cancer, not merely the gene name. A response in a different tumour type, an early laboratory study or a small case series may be less persuasive than results from a controlled trial in the same disease. The team weighs expected benefit against side effects, interactions, monitoring requirements and alternatives. Patient preferences—such as avoiding frequent infusions, preserving daily function or prioritising symptom relief—are part of the decision.
Access can determine what is feasible. Test availability differs among hospitals; costs vary; and insurance coverage depends on the test, indication and supporting evidence. An apparently suitable off-label drug may not be covered, and a relevant trial may be too far away or have closed recruitment.
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Cancers contain populations of cells that are not always molecularly identical. Treatment can eliminate cells carrying one biomarker while leaving resistant cells behind. New changes can also arise as the disease progresses. For that reason, an old biopsy may not describe a recurrence or a tumour that has grown after therapy.
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If cancer returns or progresses, the team may recommend a new tissue sample or liquid biopsy, provided the result would alter management and the procedure is safe. Retesting is not routine repetition for its own sake; it is a way to answer a new clinical question when the biology or treatment options have changed.
Independent reader supportYour contribution helps us test, update, and keep practical guides available for everyone.Why a biomarker match may still fail
Biomarker testing predicts probability, not certainty. NCI identifies several reasons a test may not lead to an effective treatment:
- The sample contains too little tumour, is degraded, or cannot be obtained safely.
- The assay fails or detects a change whose significance is unknown.
- No drug with relevant evidence is available for that cancer and treatment line.
- The alteration is present in only some tumour cells, leaving other cells unaffected.
- The cancer has evolved since the sample was collected.
- The tumour’s biology, immune environment or other molecular changes blunt the drug’s effect.
- The treatment is inaccessible because of cost, coverage, geography or trial eligibility.
NCI’s research overview emphasises that tumour heterogeneity, molecular evolution and difficulty obtaining representative samples make accurate response prediction hard. A test therefore informs a multidisciplinary decision; it is not a complete forecast of an individual outcome.
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Commercial liquid-biopsy examples illustrate why specifications must be dated and indication-specific. In a report published October 15, 2020, NCI described Guardant360 CDx as checking changes in more than 60 genes and FoundationOne Liquid CDx as assessing changes in more than 300 genes plus other features for certain approved cancer uses at that time. Those gene counts were technical descriptions from 2020, not current comparative specifications, complete indication lists or response statistics. Current FDA and manufacturer labeling must be checked before relying on a test for a present-day decision.
More genes do not automatically mean a better answer. Clinical usefulness depends on whether the assay is validated for the specimen, whether it can detect the alteration at the level present, and whether a treatment with relevant evidence exists. A broad panel can also identify findings that are biologically interesting but not actionable.
How to compare two possible targeted treatments
When more than one option appears, ask the oncology team to compare each on the same axes:
- Exact biomarker and assay: What alteration was found, at what level, and in which sample?
- Diagnostic status: Is this assay an authorised companion diagnostic for this drug and indication?
- Evidence: Were patients with this cancer and treatment history studied, and what outcomes were observed?
- Clinical fit: How do stage, prior treatments, organ function and other medicines affect suitability?
- Benefits and harms: What response, disease-control or symptom benefit is realistic, and which toxicities require monitoring?
- Alternatives: Is another approved treatment, local therapy, supportive-care plan or trial more appropriate?
- Practical access: What will testing and treatment cost, what does insurance cover, and where can treatment be delivered?
- Timing: Is the sample current, or would retesting change the choice?
Questions to take to an oncology appointment
- What exact biomarker did the test find, and which test and sample detected it?
- Is the result actionable, resistant, prognostic or uncertain?
- Is the proposed drug approved for my cancer type, stage and current treatment situation?
- If it is off-label or trial-based, what evidence supports it in people like me?
- How certain is the expected benefit, and what could make the treatment fail?
- What side effects, monitoring and drug interactions should I expect?
- What approved alternatives, local treatments or clinical trials are available?
- Was the sample adequate and recent enough, and could the tumour have changed?
- What will the test and treatment cost, and is insurance authorization required?
These questions support a discussion with the treating team; they cannot replace individualized medical advice. The practical conclusion is that doctors choose targeted therapy through a chain of evidence: a reliable biomarker result, a drug whose activity fits that biomarker and cancer, a patient who can safely receive it, and access to the treatment. If any link is weak, the team may seek more testing, choose another therapy or recommend a clinical trial instead.
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