Drugs / Trastuzumab duocarmazine
Trastuzumab duocarmazine
also known as
SYD985 · [vic-]trastuzumab duocarmazine · SYD985: (vic-)trastuzumab duocarmazine · T-Duo · Trastuzumab duocarmazina
Other / unclassified targets ERBB2
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Rejected (CRL) | US (FDA) | — | progesterone-receptor positive breast cancer | 2023-05-15 | “FDA has issued a complete response letter (CRL) for the Biological License Application (BLA) for [vic-]trastuzumab duocarmazine (SYD985).” byondis.com ↗ |
| Filed | US (FDA) | — | progesterone-receptor positive breast cancer | 2022-07-12 | “the U.S. Food & Drug Administration (FDA) accepted the company’s submission of a Biologics License Application (BLA) for [vic-]trastuzumab duocarmazine (SYD985)” byondis.com ↗ |
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT04235101 | Jun 2020 → Apr 2023 | cancer | Byondis B.V. | Completed | No outcome recorded |
| Phase 1 | NCT02277717 | Oct 2014 → Jan 2019 | cancer | Byondis B.V. | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT04205630 | May 2020 → Jan 2023 | endometrial cancer | Byondis B.V. | Completed | No outcome recorded |
| Phase 2 | NCT01042379 | Mar 2010 → Dec 2030 expected | HER2 positive breast carcinoma, angiosarcoma, female breast carcinoma, hormone receptor-positive breast cancer +1 | QuantumLeap Healthcare Collaborative | Recruiting | No outcome recorded |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT03262935 | Dec 2017 → Mar 2021 | breast cancer | Byondis B.V. | Completed | Met primary |
| Comparator or background therapy1 trial | ||||||
| Phase 1/2 | NCT04983238 Background | Jan 2022 → Apr 2023 | breast cancer | Byondis B.V. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2023-05-15 | Byondis B.V. | Regulatory U.S. Food and Drug Administration Issues Complete Response Letter for Byondis’ [Vic-]Trastuzumab Duocarmazine byondis.com ↗
Byondis B.V., an independent, Dutch clinical-stage biopharmaceutical company creating targeted medicines, today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the Biological License Application (BLA) for [vic-]trastuzumab duocarmazine (SYD985). |
| 2022-07-18 | Byondis B.V. | Regulatory EMA Validates Marketing Authorization Application for Trastuzumab Duocarmazine (SYD985) in HER2-Positive Metastatic Breast Cancer byondis.com ↗
“The MAA validation is an important step forward in our mission to make hope real for patients,” said Byondis CEO Marco Timmers, Ph.D. |
| 2022-07-12 | Byondis B.V. | Regulatory FDA Accepts Byondis’ Biologics License Application for [Vic-]Trastuzumab Duocarmazine (SYD985) in HER2-Positive Metastatic Breast Cancer byondis.com ↗
Today’s SYD985 BLA acceptance by the FDA is an important step forward toward our goal of providing a much-needed alternative for these patients. |
| 2021-10-07 | Byondis B.V. | Results Byondis World ADC Highlights byondis.com ↗
The trial, which compared SYD985 to physician's choice (PC) treatment, demonstrated a statistically significant improvement in progression-free survival (PFS) over PC. |
| 2021-09-19 | Byondis B.V. | Results Byondis ESMO Late-Breaking Presentation Confirms ADC [Vic-] Trastuzumab Duocarmazine (SYD985) Superior to Physician’s Choice in Pre-treated Locally Advanced or Metastatic HER2-Positive Breast Cancer byondis.com ↗
“SYD985 vs. Physician's Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer” met its primary endpoint of progression-free survival (PFS), demonstrating a statistically significant improvement over PC – 7 months for SYD985 versus 4.9 months for PC. |
| 2021-06-08 | Byondis B.V. | Results Byondis Announces Positive Topline Results of Pivotal Phase III TULIP® Study in Patients With HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer byondis.com ↗
The Phase III TULIP study “SYD985 vs. Physician's Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer” met its primary endpoint of progression-free survival (PFS), demonstrating a statistically significant improvement over physician’s choice. |
All press releases naming this drug 10 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Trastuzumab duocarmazine | “Trastuzumab duocarmazine is a novel HER2-targeting antibody-drug conjugate comprised of trastuzumab covalently bound to a linker drug containing duocarmycin.” PMID 31257177 ↗ Jun 2019 |
| Known as | [vic-]trastuzumab duocarmazine | “SYD985 ([vic-]trastuzumab duocarmazine)” NCT01042379 ↗1“Drug: (vic-)trastuzumab duocarmazine” NCT03262935 ↗ |
| Known as | SYD985 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04983238 ↗ |
| Known as | SYD985: (vic-)trastuzumab duocarmazine | “SYD985: (vic-)trastuzumab duocarmazine” NCT04983238 ↗ |
| Known as | T-Duo | “Trastuzumab duocarmazine (T-Duo) is a third-generation, HER2-targeted antibody-drug conjugate that demonstrated efficacy and acceptable safety in phase I studies of heavily...” PMID 39442070 ↗ Oct 2024 |
| Known as | Trastuzumab duocarmazina | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298178 ↗ |
| Action | Deplete | “subsequently kills the cancer cell.” NCT04235101 ↗ |
| Modality | Other / unclassified | “SYD985 is an antibody-drug conjugate” NCT04235101 ↗ |
| Route | Intravenous | “SYD985: 1.2 mg/kg IV” NCT01042379 ↗ |
| Target | ERBB2 | “HER2-targeted antibody-drug conjugate” PMID 39442070 ↗ Oct 2024 |