Gemcitabine intravesical system (TAR-200)
TAR-200 is a small pretzel-shaped device placed in the bladder that releases gemcitabine for three weeks at a time. It was approved in 2025 for early bladder cancer that no longer responds to BCG.
FDA approval 9 September 2025 for BCG-unresponsive NMIBC with CIS, based on SunRISe-1 (CR 82%). Placed and removed via a urinary catheter in the clinic. Phase 3 trials in BCG-naive NMIBC (SunRISe-3) and MIBC (SunRISe-4, with cetrelimab; SunRISe-2 vs chemoradiation). Johnson & Johnson (from Taris).
1.Device inserted through a urinary placement catheter and coils in the bladder
- Route
- Intravesical (indwelling device)
- Schedule
- 225 mg gemcitabine device every 3 weeks for 24 weeks, then every 12 weeks up to 3 years
- Monitoring
- Cystoscopy and cytology at 3-month intervals
- Medicare
- Part B (clinician-administered)
Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. Intravesical drug-releasing system placed in the urology clinic; approved 2025 and newly assigned coding, so check the local Medicare contractor.
- Commercial insurance
- covered with prior authorisation
Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments. New product; expect plan policies to lag the approval by several months.
- Assistance programmes
- Johnson & Johnson withMe
- Johnson & Johnson Patient Assistance Foundation
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.
- Notes
- No UK marketing authorisation as of September 2026, so no NICE appraisal. Access only through a clinical trial or a company early access scheme.
- NHS England
- Not routinely funded
Sources: NICE search: TAR-200 (gemcitabine intravesical system). Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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- 9 Sept 2025ApprovalUS
FDA approval of Inlexzo source
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2025 | BCG-unresponsive high-risk NMIBC with CIS, with or without papillary tumours |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Urinary tract infection | 24% | — |
| Dysuria | 22% | — |
| Pollakiuria | 20% | — |
| Grade 3+ treatment-related | — | 12% |
Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
Latest papers
topQuery for this drug: (TITLE:"Gemcitabine intravesical system" OR ABSTRACT:"Gemcitabine intravesical system" OR TITLE:"TAR-200" OR ABSTRACT:"TAR-200" OR TITLE:"Inlexzo" OR ABSTRACT:"Inlexzo") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Gemcitabine intravesical system (TAR-200), not a curated reading list.