What is SKB264, and is it the same as Trodelvy?
SKB264 is sacituzumab tirumotecan, also called sac-TMT or MK-2870 and marketed in China as 佳泰莱. It is a TROP2-directed antibody–drug conjugate (ADC): an antibody carries a cell-killing payload toward tumor cells.
It is a different medicine from sacituzumab govitecan (Trodelvy). Both target TROP2, but their indications, evidence and treatment schedules differ. Send the exact drug names when requesting review, especially if you have already received an ADC.
Who is SKB264 approved for?
Kelun-Biotech reports Chinese approvals for the adult patient groups below. For breast cancer, subtype and prior treatment matter; for lung cancer, the key requirements are EGFR mutation, nonsquamous histology and progression after EGFR-targeted therapy.
| Cancer type | Key requirements in the approved setting |
|---|---|
| Triple-negative breast cancer (TNBC) | Unresectable locally advanced or metastatic disease; at least 2 previous systemic therapies, including at least 1 for advanced or metastatic disease. |
| HR-positive / HER2-negative breast cancer | Unresectable or metastatic disease after endocrine therapy and at least 1 chemotherapy line in the advanced setting. HER2 includes IHC 0, IHC 1+, or IHC 2+ with negative ISH. |
| EGFR-mutated nonsquamous NSCLC | Locally advanced or metastatic disease progressing after an EGFR-TKI. The earlier post-TKI-and-platinum setting has its own evidence; the expanded indication does not require every patient to have received platinum chemotherapy first. |
Where can treatment be arranged?
These are Chinese approvals. Chirona can arrange assessment through partner hospitals and coordinate care after confirming the indication, treating specialist, treatment arrangements and costs. Approval in China does not establish local licensing, supply or insurance coverage in your home country; those access and payment questions need separate confirmation.
What benefit has been shown for my cancer type?
Different patient groups have different studies. Progression-free survival measures time before cancer progression or death. Lung-cancer results do not predict breast-cancer benefit, and results from separate trials cannot rank treatments against each other.
| Patients and study | Comparison and source |
|---|---|
| Previously treated TNBC · OptiTROP-Breast01 | 263 patients; SKB264 versus physician-selected chemotherapy. Median progression-free survival: 6.7 versus 2.5 months. Peer-reviewed publication in Nature Medicine. |
| Previously treated HR+/HER2− breast cancer · OptiTROP-Breast02 | SKB264 versus physician-selected chemotherapy. Median progression-free survival: 8.3 versus 4.1 months, from the sponsor’s report of ESMO 2025 findings. All study patients had received a CDK4/6 inhibitor and a taxane. |
| Nonsquamous lung cancer after EGFR-TKI progression · OptiTROP-Lung04 | 376 patients; SKB264 versus platinum–pemetrexed. Median progression-free survival: 8.3 versus 4.3 months, with an overall-survival benefit also reported. Peer-reviewed publication in NEJM. |
How should these results inform my next step?
If your subtype and treatment history match and your current treatment no longer controls the cancer, SKB264 is an option to discuss with a specialist. The comparison should include endocrine, targeted, other ADC or chemotherapy options relevant to you, together with previous side effects. Trial results describe benefit in defined groups, not a guaranteed individual outcome or a reason to stop treatment that is still working.
Do my reports and previous treatments fit?
Use the checklist for your cancer type so the specialist can assess the indication, alternatives and your health. A treatment “line” means a regimen used at a particular stage—not the number of infusions.
Breast cancer: distinguish TNBC from HR+/HER2− disease
Send the full ER, PR and HER2 pathology results, including ISH when HER2 is IHC 2+. Include any biopsy of a metastatic site. “HER2-low” alone is not enough: hormone-receptor status and prior treatment still determine the pathway.
- TNBC: identify at least 2 previous systemic therapies and which was given for advanced or metastatic disease. Separate treatment before surgery, after surgery and after recurrence; two infusions are not two therapies.
- HR+/HER2−: list endocrine drugs, CDK4/6 inhibitors and chemotherapy. The approved setting requires prior endocrine treatment and at least 1 chemotherapy line for advanced disease. Progression on endocrine treatment without prior advanced-setting chemotherapy does not by itself meet that indication.
- HER2-positive or uncertain pathology: do not apply the two pathways above. Confirm the test results and subtype before comparing treatment options.
Lung cancer: confirm EGFR, nonsquamous histology and post-TKI progression
The approved lung-cancer pathways described here concern EGFR-mutated, locally advanced or metastatic nonsquamous NSCLC. They do not apply to every lung cancer or follow from PD-L1 or TROP2 positivity alone.
- Molecular and pathology reports: include the exact EGFR alteration, histological subtype and recent imaging. Send any resistance testing or repeat biopsy already performed.
- Targeted treatment history: record Tagrisso (osimertinib) or other EGFR-TKI names, treatment dates, initial response and when progression was found. These help define the next treatment decision.
- Have you received chemotherapy? Include the platinum regimen, cycles and response—or state that none has been given. The Chinese indication expanded in September 2025 to disease progressing after EGFR-TKI treatment; platinum chemotherapy is not a universal prerequisite. Progression sites, repeat tests and other available options still affect the choice.
What changes after a previous ADC?
Record the previous antibody target, payload, treatment duration and reason for stopping. Progression on a drug and stopping because of toxicity are different situations. Ask whether the evidence for sac-TMT includes patients with that exposure; a new brand name or the same TROP2 target does not answer the sequencing question.
How is treatment given, and what needs monitoring?
Intravenous treatment requires blood-count monitoring and assessment for infection, mouth inflammation, gastrointestinal symptoms and other treatment-related toxicity. New cough or breathlessness needs assessment rather than being assumed to be cancer progression. Dose delays or adjustments depend on the actual product label and the patient’s recovery.
Make recovery part of the treatment plan
- Before an infusion: review blood counts and recovery, and agree on mouth care, nausea management and nutrition. The treating team decides whether the next dose can proceed.
- Between visits: mouth soreness can affect eating and drinking, while low blood counts can increase infection risk. Contact the team promptly for fever, marked weakness or difficulty maintaining food and fluid intake.
- New breathing symptoms: new cough or breathlessness needs prompt assessment. Confirm local urgent-care arrangements before travel rather than waiting for the next scheduled visit.
How much could treatment cost?
US$16,000–52,000
What’s included
This estimate covers total medical treatment costs, including medication, specialist consultations and assessment, pretreatment tests, routine laboratory and imaging follow-up, treatment administration and nursing, necessary hospitalization and monitoring, and routine supportive care. Travel and accommodation are not included.
Serious complications, ICU care or additional anticancer treatments may incur separate costs. Confirm coordination-service fees separately in the written estimate.
Your individual treatment costs
Most ongoing drug treatments do not have a fixed treatment duration, and costs accumulate with the number of treatments received. Your prescribed dose, combination therapies and care needs also affect the total. This range is indicative only; your individual costs may fall outside it. Contact us for a personalized cost estimate based on your medical needs and specialist assessment.
The shared reference range does not mean breast and lung cancer require identical tests, treatment duration or spending. We help obtain an individual estimate based on weight and prescription, planned infusions, monitoring and hospital needs. This is not a fixed-course package or a spending cap.
How can Chirona arrange my specialist review?
Identify the right treatment pathway before arranging care. Chirona coordinates review with breast or thoracic oncology specialists at partner hospitals, connecting your records, treatment plan, costs and travel arrangements.
1. Prepare the right records and arrange review
For breast cancer, send ER/PR/HER2 and any required ISH results with endocrine, chemotherapy and ADC records. For lung cancer, send pathology, EGFR results, TKI history and scans showing progression. We organize the records and arrange the relevant specialist to clarify eligibility, missing tests and alternatives.
2. Confirm the treating center, plan and costs
Once the specialist agrees a plan, we coordinate partner-hospital appointments, treatment arrangements, a written medical cost estimate, language support and travel. Confirm the initial review and infusion dates, further tests or hospital stays, and separate medical, coordination and travel costs before departure.
3. Arrange monitoring between visits and follow-up at home
Agree on blood tests, mouth and nutrition support, follow-up scans and urgent contacts with the treating team. We help organize treatment records for your home doctors. Where and when later infusions take place depends on response, tolerability and local access.
Evidence & sources
Prepared by Chirona’s content team from the sources below. This guide supports a discussion with your treating team; it does not determine an individual treatment plan.
- Kelun-Biotech: four approved indications and 2026 development
- Kelun-Biotech: HR-positive/HER2-negative breast cancer approval, 2026
- NEJM: OptiTROP-Lung04 randomized Phase III trial
- FDA: first-line sacituzumab govitecan approvals, June 2026
- Kelun-Biotech: product information and four Chinese indications
- Nature Medicine: OptiTROP-Breast01 randomized Phase III trial