Disitamab vedotin
Disitamab vedotin is a Chinese HER2 ADC approved for gastric and bladder cancer, now in global trials with Pfizer.
Approved in China (2021) for HER2+ gastric cancer and HER2-expressing urothelial cancer. Phase 3 with toripalimab in first-line HER2-expressing urothelial cancer was positive (2025). Pfizer (via Seagen) holds ex-China rights.
1.Antibody binds HER2 on the tumour cell surface
- Route
- IV infusion
- Schedule
- 2.0 mg/kg every 2 weeks (China label)
- Monitoring
- Peripheral neuropathy, neutropenia, LFTs
Source: www.remegen.com. Doses are for orientation; the current label governs.
- Medicare
- Not covered (not FDA-approved)
Not FDA-approved, so there is no US coverage; access is only through a clinical trial or an FDA expanded-access request.
- Commercial insurance
- unknown
Not FDA-approved, so there is no US coverage; access is only through a clinical trial or an FDA expanded-access request.
Sources: CMS Medicare Coverage Database (NCDs and LCDs). 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: disitamab vedotin. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Compare all products across the US, EU, UK, Japan, China and Australia →
- Sept 2020DesignationUS
Breakthrough Therapy designation, HER2+ urothelial cancer source
- Jun 2021ApprovalChina
Conditional approval, HER2+ gastric cancer after ≥2 lines source
- 31 Dec 2021ApprovalChina
HER2-expressing urothelial cancer after platinum source
- Dec 2025Filing / dealChina
First-line urothelial cancer with toripalimab, positive phase 3 source
Approvals
| Region | Year | Indication |
|---|---|---|
| China | 2021 | HER2+ gastric cancer; HER2-expressing urothelial cancer |
| Adverse event |
|---|
| Peripheral neuropathy |
| Neutropenia |
| Alopecia |
| AST/ALT increased |
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.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| China | NMPA approved 2021; on the National Reimbursement Drug List | not disclosed | — |
| United States | Investigational (Pfizer; phase 3 in urothelial cancer) | not disclosed | — |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
Trials
topRecruiting now (live from ClinicalTrials.gov)
Country and place are remembered in this browser only. A postcode is sent to OpenStreetMap's Nominatim service to find coordinates when you press the button; nothing else leaves your device.
Latest papers
topQuery for this drug: (TITLE:"Disitamab vedotin" OR ABSTRACT:"Disitamab vedotin" OR TITLE:"RC48" OR ABSTRACT:"RC48") 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 Disitamab vedotin, not a curated reading list.
Pages like this
not linked directly; found by shared links- ProductTisotumab vedotin
Shares mc-Val-Cit-PABC, MMAE, Tubulin inhibitor payloads, Pfizer (incl. Seagen).
- ProductTelisotuzumab vedotin
Shares mc-Val-Cit-PABC, MMAE, Tubulin inhibitor payloads, Antibody-drug conjugate (ADC).
- ProductARX788
Shares Sequencing HER2 ADCs by payload after T-DXd, HER2, HER2-positive breast cancer, Antibody-drug conjugate (ADC).
- ProductSonesitatug vedotin
Shares MMAE, Tubulin inhibitor payloads, Gastric & gastro-oesophageal junction cancer, Antibody-drug conjugate (ADC).
- ProductEnfortumab vedotin
Shares mc-Val-Cit-PABC, MMAE, Tubulin inhibitor payloads, Pfizer (incl. Seagen).
- PersonFei Ma
Shares Cancer Hospital, Chinese Academy of Medical Sciences, HER2, HER2-positive breast cancer.
- ProductZilovertamab vedotin
Shares MMAE, Tubulin inhibitor payloads, Antibody-drug conjugate (ADC).
- TermBystander effect (ADC)
Shares mc-Val-Cit-PABC, MMAE, Tubulin inhibitor payloads, Antibody-drug conjugate (ADC).