# Disitamab vedotin

Source: https://onco.cc/drugs/disitamab-vedotin/  
OnCo record `disitamab-vedotin` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Disitamab vedotin is a Chinese HER2 ADC approved for gastric and bladder cancer, now in global trials with Pfizer.

## Summary

Disitamab vedotin is an anti-HER2 antibody (hertuzumab) linked through a cleavable mc-vc-PABC linker to the microtubule inhibitor MMAE, whose membrane permeability lets it kill neighbouring cells with lower HER2 expression. Developed by RemeGen, it was approved in China in 2021 for HER2-positive gastric cancer after two or more lines and for HER2-expressing urothelial cancer after platinum, and is given at 2.0 mg/kg every 2 weeks. A phase 3 trial with toripalimab in first-line HER2-expressing urothelial cancer was positive in 2025, and the FDA granted Breakthrough Therapy designation in HER2-positive urothelial cancer in 2020. Pfizer, via Seagen, holds ex-China rights and is running global trials. Peripheral neuropathy, neutropenia, alopecia and raised transaminases are the main toxicities. It is a Chinese HER2 ADC now heading into global development.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-04
- Code: RC48
- Modality: ADC
- Mechanism: Anti-HER2 (hertuzumab) with MMAE.
- Payload: MMAE
- Linker: mc-vc-PABC
- Approvals: China 2021: HER2+ gastric cancer; HER2-expressing urothelial cancer
- Dosing: IV infusion; 2.0 mg/kg every 2 weeks (China label)

## Sources

- FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Disitamab%20vedotin

## Connected records

- cancers: [Bladder & urothelial cancer](https://onco.cc/cancers/urothelial/), [Gastric & gastro-oesophageal junction cancer](https://onco.cc/cancers/gastric/), [HER2-low and HER2-ultralow metastatic breast cancer](https://onco.cc/cancers/her2-low-metastatic-breast-cancer/), [HER2-positive breast cancer](https://onco.cc/cancers/breast-her2-positive/), [HER2-positive gastric cancer](https://onco.cc/cancers/gastric-her2-positive/)
- technologies: [Antibody-drug conjugate (ADC)](https://onco.cc/technologies/adc/)
- targets: [HER2](https://onco.cc/targets/her2/)
- companies: [Pfizer (incl. Seagen)](https://onco.cc/companies/pfizer/), [RemeGen](https://onco.cc/companies/remegen/)
- terms: [mc-Val-Cit-PABC](https://onco.cc/terms/mc-vc-pabc/), [MMAE](https://onco.cc/terms/mmae/), [Tubulin inhibitor payloads](https://onco.cc/terms/tubulin-inhibitor-payloads/)
- trials: [A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2](https://onco.cc/trials/nct04879329/), [A Study of Disitamab Vedotin Combined With Trastuzumab and Tislelizumab Versus Chemotherapy Combined With Trastuzumab With or Without Pembrolizumab in HER2-high Expression Advanced Gastric or Gastroesophageal Junction Adenocarcinoma.](https://onco.cc/trials/nct07315750/), [A Study of Disitamab Vedotin in Adults With HER2 Expressing Advanced Breast Cancer](https://onco.cc/trials/nct06966453/), [A Study of Disitamab Vedotin in Previously Treated Solid Tumors That Express HER2](https://onco.cc/trials/nct06003231/), [A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors](https://onco.cc/trials/nct06157892/), [A Study of RC48-ADC Combination With Zimberelimab Injection Therapies at Least First-line Platinum-containing Standard Therapy Failed With Recurrent o](https://onco.cc/trials/nct06155396/), [A Trial of SHR-A2102 With or Without Antitumor Therapy in Advanced Solid Tumors](https://onco.cc/trials/nct06417554/), [Disitamab Vedotin Plus Lenvatinib and PD-1 Inhibitors for Treating HER2-positive Advanced Biliary Tract Cancer](https://onco.cc/trials/nct07159217/), [Disitamab Vedotin With Pembrolizumab vs Chemotherapy in Previously Untreated Urothelial Cancer Expressing HER2](https://onco.cc/trials/nct05911295/), [DV Combined With Cadonilimab in Subjects With HER2-expressing Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on First-line Therapy](https://onco.cc/trials/nct06221748/), [DV in Combination With Pertuzumab With or Without Toripalimab Neoadjuvant Therapy With HER2-positive Breast Cancer](https://onco.cc/trials/nct06178159/), [Efficacy and Safety Study of Disitamab Vedotin + RC148 vs. Albumin-Paclitaxone ± Toripalimab in HR-/HER2-low Breast Cancer](https://onco.cc/trials/nct06642545/), [Neoadjuvant Study of DV in Combination Toripalimab or Sequence Chemotherapy in HR-negative, HER2 Low-expressing Breast Cancer](https://onco.cc/trials/nct06227117/), [Perioperative Disitamab Vedotin Plus Toripalimab and XELOX in Gastric or Gastroesophageal Junction Adenocarcinoma.](https://onco.cc/trials/nct06155383/), [RC48 Combined With Chemotherapy in HER2-Positive Advanced Breast Cancer Patients With Prior TOP1i-ADC Failure](https://onco.cc/trials/nct07366840/), [To Evaluate the Efficacy and Safety of Disitamab Vedotin Combined With Toripalimab Sequential Chemotherapy as Neoadjuvant Treatment in Patients With HR-positive, HER2-low Breast Cancer](https://onco.cc/trials/nct06389006/), [To Evaluate the Safety, Efficacy, and Pharmacokinetics of Intravesical Instiliations of Disitamab Vedotin in Patients With High-risk Non-muscular Invasive Bladder Cancer (NMIBC) That Express HER2](https://onco.cc/trials/nct06378242/)
- ideas: [Sequencing HER2 ADCs by payload after T-DXd](https://onco.cc/ideas/idea-her2-adc-sequencing-payload/)
- institutions: [Cancer Hospital, Chinese Academy of Medical Sciences](https://onco.cc/institutions/cams-cancer-hospital/), [National Medical Products Administration / Center for Drug Evaluation](https://onco.cc/institutions/nmpa-cde/), [Peking University Cancer Hospital](https://onco.cc/institutions/pku-cancer-hospital/)
- people: [Dingwei Ye](https://onco.cc/people/ye-dingwei/), [Jianming Xu](https://onco.cc/people/xu-jianming/)
- pathways: [Bladder cancer (KEGG map)](https://onco.cc/pathways/bladder-cancer-signalling/)

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