Trastuzumab and Trastuzumab Deruxtecan in Breast Cancer
Trastuzumab has been part of Indian breast cancer treatment since the early 2000s, and trastuzumab deruxtecan reached India in January 2024. Families researching immunotherapy arrive at both, because hospitals and insurers here often file them under that heading. They are not the same medicine, they are not priced anything alike, and neither is immunotherapy in the sense most people mean. This page separates them, sets out who each is actually for under current Indian approvals, and gives the indicative cost picture for both as of August 2026.
Medically reviewed by Dr. C. Raghavendra Reddy, Medical Oncologist, MBBS (Gold Medal) · DNB · DM (Medical Oncology, Gold Medal) · Last reviewed August 2026
Are trastuzumab and trastuzumab deruxtecan immunotherapy?
Neither is immunotherapy in the checkpoint-inhibitor sense. Trastuzumab is a HER2-targeted monoclonal antibody. Part of how it works is by flagging HER2-positive cells for the patient’s own immune cells to destroy, which is why India often files it under immunotherapy. Trastuzumab deruxtecan is an antibody-drug conjugate — a similar antibody carrying a chemotherapy payload.
This is the single most useful thing to settle first, because the word is used three different ways in an Indian hospital corridor. A monoclonal antibody points the immune system at a specific target on the tumour. A checkpoint inhibitor releases a brake on T cells that already recognise the tumour. An antibody-drug conjugate uses the antibody as a delivery vehicle, so chemotherapy is released mainly inside cells carrying the target protein.
Trastuzumab belongs in the first group and has done since it entered Indian practice in the early 2000s. That is the part patients are rarely told: a treatment a mother or an aunt may have had a decade ago is described today, quite reasonably, as an immune-directed therapy. Trastuzumab deruxtecan belongs in the third group. Pembrolizumab and nivolumab belong in the second.
| Trastuzumab | Trastuzumab deruxtecan | Checkpoint inhibitors | |
|---|---|---|---|
| Class | HER2-targeted monoclonal antibody | HER2-directed antibody-drug conjugate | PD-1 or PD-L1 immune checkpoint inhibitor |
| What it acts on | The HER2 protein on the tumour cell | The HER2 protein, then delivers chemotherapy inside the cell | A signal on immune cells, not on the tumour |
| Immune involvement | Partly — it marks cells for the patient’s immune cells | Partly, through the same antibody | Entirely — it works only through the immune system |
| Carries a chemotherapy payload | No | Yes, a topoisomerase I inhibitor payload | No |
| Selected by | HER2 test on the tumour | HER2 test on the tumour | PD-L1, MSI or TMB testing, depending on the cancer |
| Indian similar biologics on the market | Several, since 2014 | None — patented import, single supplier | One nivolumab biosimilar so far, from January 2026 |
| Notified price ceiling in India | Yes — it is on the National List of Essential Medicines | No | No |
Compiled from approved product information, CDSCO approval announcements and reported Indian coverage, accurate to August 2026. Classification is a scientific description, not a ranking — no medicine in this table is better or worse than another, and none of them substitutes for another.
Which patients are these medicines for?
Only patients whose tumour expresses HER2 — and, for trastuzumab deruxtecan in some settings, HER2-low or HER2-ultralow disease. HER2 status comes from immunohistochemistry, confirmed where needed by in-situ hybridisation. In India, HER2-positive disease is estimated at roughly 12 to 19 per cent of breast cancers. The pathology report decides eligibility, long before cost does.
Trastuzumab is approved for HER2-positive breast cancer, in both early and metastatic settings, and for HER2-positive gastric and gastro-oesophageal cancer. It is on the World Health Organization’s Model List of Essential Medicines and on India’s National List of Essential Medicines. In HER2-negative disease it does nothing at all, and no price makes it appropriate.
Trastuzumab deruxtecan reached India much later, and its approvals are setting-specific rather than general. AstraZeneca Pharma India received permission from the Drug Controller General of India to import and market it in May 2023 and launched it here in January 2024. CDSCO has approved further indications since, each announced publicly.
| Indication approved in India | Setting | Announced |
|---|---|---|
| HER2-positive unresectable or metastatic breast cancer, after a prior anti-HER2 regimen | Metastatic, after earlier HER2-directed treatment | DCGI import and marketing approval May 2023; Indian launch January 2024 |
| HER2-low and HER2-ultralow breast cancer | Specified metastatic settings | CDSCO, May 2025 |
| HER2-positive (IHC 3+) solid tumours after prior systemic therapy, where no satisfactory alternative exists | Tumour-agnostic, unresectable or metastatic | CDSCO, October 2025 |
| With pertuzumab, HER2-positive (IHC 3+ or ISH+) breast cancer | First line, unresectable or metastatic | CDSCO, June 2026 |
| HER2-positive stage II or III breast cancer | Neoadjuvant, before surgery | CDSCO, reported July 2026 |
| HER2-positive gastric or gastro-oesophageal junction adenocarcinoma, after a prior anti-HER2 regimen | Locally advanced or metastatic | Listed among current approved indications, June 2026 |
Compiled from AstraZeneca Pharma India CDSCO approval announcements and reported Indian coverage, accurate to August 2026. Approval status changes, and a treating oncologist works from the current approved product information rather than from a web page. This table records what has been approved for use in India; it is not a statement that any particular patient should receive it.
Where the evidence for the tumour-agnostic indication came from: the October 2025 CDSCO approval announcement cited three multicentre studies in 192 previously treated patients, reporting confirmed objective response rates of 51.4 per cent, 52.9 per cent and 46.9 per cent across the three. Those are response rates in selected trial populations, not a prediction for any individual, and they say nothing about how long a response lasts.
What is the indicative cost of trastuzumab deruxtecan in India?
Reported Indian coverage in July 2026 put it at around ₹1.6 lakh per 100 mg vial — indicative, as of August 2026. A vial price is not a cycle price. At the labelled breast-cancer dose of 5.4 mg per kg every three weeks, an adult of around 60 kg needs roughly four vials a cycle. Plain trastuzumab sits at a completely different level.
| Item | Indicative figure* | Published source for the figure |
|---|---|---|
| Trastuzumab deruxtecan, 100 mg vial | Around ₹1.6 lakh | Reported Indian market coverage, July 2026 |
| Trastuzumab deruxtecan, vials per cycle, adult of about 60 kg | About four vials every three weeks | Arithmetic on the labelled 5.4 mg/kg breast-cancer dose — not a quotation |
| Trastuzumab, reference brands, 440 mg vial, 2013 | About ₹75,000 | Reported at the launch of lower-priced Indian brands |
| Trastuzumab, lowest reported launch MRP, 440 mg vial | ₹19,995, April 2019 | Manufacturer launch announcement |
| Trastuzumab, DPCO ceiling price, 440 mg/50 ml pack | In the region of ₹55,000 | NPPA notification; revised annually against the wholesale price index |
| Trastuzumab, full 18-cycle course at biosimilar prices | Under ₹4 lakh | Estimate cited in April 2019 Indian launch reporting |
*Indicative only, as of August 2026. Compiled from published manufacturer launch announcements, NPPA ceiling-price notifications and reported Indian coverage — not a CION price, not a price list, and not a quotation for any patient. What a family actually pays depends on body weight, which sets the dose, on how many vials each cycle needs, on the brand the hospital pharmacy stocks, and on how long treatment runs.
The honest limit of any total. In the metastatic setting, trastuzumab deruxtecan is given until the disease progresses or the side effects become unacceptable — not for a fixed number of cycles. A total course figure therefore cannot be stated in advance by anyone, and a quoted total should be read as an assumption about duration rather than as a fact. Adjuvant trastuzumab is the opposite case: a planned course, usually around 17 to 18 three-weekly cycles, which can be costed in advance.
Three questions that move the number more than the brand does. How many cycles are planned, or on what basis treatment will be reviewed if the number is open-ended. What dose body weight gives, since that decides the vial count. And whether the estimate separates the drug from day-care, monitoring and consultation charges — an itemised estimate makes every other question answerable.
Who this is not for
Most people with breast cancer are candidates for neither medicine, and no price changes that. Both act only where the tumour expresses HER2, and trastuzumab deruxtecan is approved for defined settings rather than as a general option. Eligibility is decided by a pathology report and a treatment plan, not by a budget.
- Not for HER2-negative cancer. If the report reads IHC 0 or 1+, or IHC 2+ with a negative in-situ hybridisation test, plain trastuzumab has no role at any price. HER2-low is a separate category and is not an indication for trastuzumab itself.
- Not a general-purpose upgrade. Trastuzumab deruxtecan is approved in India for specific settings, several of them only after a prior anti-HER2 regimen. Being HER2-positive does not by itself place a patient in one of those settings.
- Not where heart pumping function is already significantly reduced, without cardiology input. Both medicines can lower the ejection fraction. An echocardiogram or MUGA scan is done before starting and repeated during treatment, and a low baseline reading can mean treatment is deferred, monitored more closely, or not used.
- Not straightforward where significant lung disease already exists. Trastuzumab deruxtecan carries a recognised risk of interstitial lung disease, sometimes serious. Pre-existing lung disease changes the risk calculation, and that is a matter for the treating team rather than for a web page.
- Not in pregnancy. Both can harm a developing baby. Effective contraception is advised during treatment and for a period afterwards; the interval is set by the treating team.
- Not a substitute for the rest of the plan. Both are given alongside surgery, chemotherapy or radiotherapy where those are indicated, never instead of them. Choosing one in place of a recommended treatment is not a cost saving.
The two are also not interchangeable with each other. A trastuzumab biosimilar is not a lower-cost trastuzumab deruxtecan, and trastuzumab emtansine is a third, separate antibody-drug conjugate again. Which of the three a prescription actually names is worth confirming in writing before any cost planning begins.
Why does trastuzumab cost a fraction of trastuzumab deruxtecan?
Patent position and competition, not clinical worth. Trastuzumab lost exclusivity in India more than a decade ago, and several approved similar biologics now compete on price. It also sits on the National List of Essential Medicines, so NPPA notifies a ceiling price that every brand must respect. Trastuzumab deruxtecan is a patented import with one supplier and no notified ceiling.
India’s trastuzumab market is the closest thing the country has to a completed biosimilar case study. The first Indian similar biologics arrived in 2014 at a modest discount. The steep fall came about five years later, once several suppliers were competing and price control had been applied. Trastuzumab Biosimilars in India sets out that price arc in full, including which brands are sold here and what comparability means when a regulator approves a similar biologic.
None of that has happened for trastuzumab deruxtecan, and none of it is close. It is a patented molecule, imported rather than made here, with a single company marketing it and no similar biologic in sight. Antibody-drug conjugates are also genuinely harder and costlier to manufacture than a plain antibody, because the payload and the chemical linker have to be produced and attached to a consistent standard. Waiting for a price fall is not a plan: delaying treatment to chase a future price is a clinical decision with clinical consequences.
The same pattern separates the rest of this class. Which Antibody Medicines Are Available in India? maps which antibodies are marketed here and where each sits on the patent-and-competition curve, and Immunotherapy Medicines Explained is the index of individual molecules and their Indian cost picture.
What monitoring do these two medicines need?
Heart function for both, and lungs for trastuzumab deruxtecan. Both antibodies can reduce the heart’s pumping function, so an echocardiogram or MUGA scan is done before starting and at intervals during treatment. Trastuzumab deruxtecan carries an additional recognised risk of interstitial lung disease, which is why a new cough or breathlessness is treated as urgent.
| Concern | Which medicine | How it is monitored | Symptom that needs same-day medical attention |
|---|---|---|---|
| Reduced heart pumping function | Both | Echocardiogram or MUGA before starting, then at intervals | Breathlessness lying flat, swelling of the ankles, sudden weight gain |
| Interstitial lung disease (pneumonitis) | Trastuzumab deruxtecan | Symptom review at every visit; imaging if it is suspected | New or worsening cough, breathlessness or fever — go to the treating hospital the same day |
| Low white cell count | Trastuzumab deruxtecan | Blood counts before each cycle | Fever, shivering or rigors — go to the emergency department immediately |
| Infusion reaction | Both | Observation during and after the infusion | Rash, breathing difficulty or chest tightness during an infusion — tell the day-care nurse at once |
| Nausea and vomiting | Trastuzumab deruxtecan more than trastuzumab | Anti-sickness medicines are planned in advance with the cycle | Vomiting that stops fluids going down, or no urine passed for a day |
General information from approved product information and published guidance, as of August 2026. The monitoring schedule for an individual is set by the treating oncologist.
One point that should not be softened. A new cough, new breathlessness or a fever while on trastuzumab deruxtecan is not something to manage at home, and not something to raise at the next cycle. Interstitial lung disease is a recognised and potentially serious effect of this medicine. Anyone with those symptoms should go to the hospital treating them the same day, and should say which medicine they are on when they arrive.
Both medicines are given as day-care infusions, so a treatment day does not usually require admission. Antibody-drug conjugates as a group share this monitoring pattern rather than the checkpoint-inhibitor one — Brentuximab Vedotin: Uses, Cost and Side Effects covers the equivalent picture for the antibody-drug conjugate used in Hodgkin lymphoma, and Cetuximab and Nimotuzumab in Head and Neck Cancer covers two plain antibodies whose Indian price story is different again.
Trastuzumab and trastuzumab deruxtecan: frequently asked questions
Are trastuzumab and trastuzumab deruxtecan immunotherapy?
Neither is immunotherapy in the checkpoint-inhibitor sense, which is what most people mean by the word. Trastuzumab is a HER2-targeted monoclonal antibody. Part of how it works is by flagging HER2-positive cells for destruction by the patient's own immune cells, which is why Indian hospitals and insurers often file it under immunotherapy. Trastuzumab deruxtecan is an antibody-drug conjugate: the same kind of HER2-targeted antibody, chemically linked to a chemotherapy payload that is released inside the tumour cell. Pembrolizumab and nivolumab work differently again, by releasing a brake on T cells rather than by targeting a protein on the tumour. The distinction matters most for cost planning, because the three sit at completely different price levels in India.
Which patients can receive trastuzumab deruxtecan in India?
Only patients whose tumour has been shown to express HER2, and only in the settings CDSCO has approved. Those settings, as of August 2026, are HER2-positive unresectable or metastatic breast cancer after a prior anti-HER2 regimen; HER2-low and HER2-ultralow breast cancer in specified metastatic settings; locally advanced or metastatic HER2-positive gastric or gastro-oesophageal junction adenocarcinoma after a prior anti-HER2 regimen; unresectable or metastatic HER2-positive IHC 3+ solid tumours after prior systemic therapy where no satisfactory alternative exists; with pertuzumab as first-line treatment in unresectable or metastatic HER2-positive breast cancer; and neoadjuvant treatment of HER2-positive stage II or III breast cancer. Whether any of these applies to an individual is a decision for the treating oncologist, based on the pathology report.
What is the indicative cost of trastuzumab deruxtecan in India?
Reported Indian coverage in July 2026 put trastuzumab deruxtecan at around Rs 1.6 lakh per 100 mg vial. That figure is indicative, as of August 2026, and is not a price offered by any hospital on this page. A vial price is also not a cycle price. At the labelled breast-cancer dose of 5.4 mg per kg every three weeks, an adult of around 60 kg needs roughly four 100 mg vials each cycle, and treatment in the metastatic setting continues until the disease progresses or the side effects become unacceptable rather than for a fixed number of cycles. That means a total course cost genuinely cannot be quoted in advance.
Is trastuzumab deruxtecan the same as a trastuzumab biosimilar?
No, and this is the most expensive misunderstanding on the topic. A trastuzumab biosimilar is a similar biologic version of plain trastuzumab, approved in India since 2014 and sold by several manufacturers. Trastuzumab deruxtecan is a different medicine altogether: an antibody-drug conjugate, patented, imported by a single company, with its own approved indications, its own side-effect profile and its own price. It is not a brand of trastuzumab and a trastuzumab biosimilar is not a cheaper version of it. Trastuzumab emtansine, sometimes written T-DM1, is a third and separate antibody-drug conjugate. Confirming which of the three a prescription actually names is worth doing before any cost planning begins.
Who should not receive trastuzumab or trastuzumab deruxtecan?
Anyone whose tumour does not express HER2. If the pathology report reads HER2-negative, plain trastuzumab has no role at any price, and HER2-low is a separate category that is not an indication for trastuzumab itself. Both medicines are used with caution, or not at all, in people whose heart pumping function is already significantly reduced, because both can lower it further, so an echocardiogram or MUGA scan is done before starting and at intervals afterwards. Trastuzumab deruxtecan additionally carries a recognised risk of interstitial lung disease, so existing significant lung disease changes the calculation. Neither medicine is given in pregnancy. Neither replaces surgery, chemotherapy or radiotherapy.
Does trastuzumab deruxtecan have Indian regulatory approval?
Yes. AstraZeneca Pharma India received permission from the Drug Controller General of India to import and market trastuzumab deruxtecan in May 2023, and launched it in India in January 2024 for HER2-positive metastatic breast cancer after a prior anti-HER2 regimen. CDSCO has since approved further indications: HER2-low and HER2-ultralow metastatic breast cancer in May 2025, a tumour-agnostic indication in HER2-positive IHC 3+ solid tumours in October 2025, use with pertuzumab as first-line metastatic breast cancer treatment in June 2026, and neoadjuvant use in stage II or III breast cancer reported in July 2026. Approval status changes over time, so treat this list as accurate to August 2026.