Drugs / CANTUZUMAB RAVTANSINE
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | CanAg-expressing cancers | 2005-03-31 | “today announced that it has submitted an Investigational New Drug application (IND) to the US Food and Drug Administration (FDA) for its huC242-DM4 targeted anticancer therapeutic.” abbvie.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00352131 | Feb 2005 → Dec 2009 | malignant pancreatic neoplasm | ImmunoGen, Inc. | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT00620607 | May 2007 → May 2010 | gastric neoplasm, gastroesophageal cancer | ImmunoGen, Inc. | Withdrawn | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2008-06-01 | AbbVie | Results ImmunoGen, Inc. Announces Clinical Findings Reported at ASCO with Targeted Anticancer Compounds IMGN242 and AVE1642 abbvie.com ↗ |
| 2008-04-08 | AbbVie | Results ImmunoGen, Inc. Announces Presentations at the American Association for Cancer Research 2008 Annual Meeting abbvie.com ↗ |
| 2007-10-24 | AbbVie | Results ImmunoGen, Inc. Reports New Clinical and Preclinical Data at AACR-NCI-EORTC abbvie.com ↗
We're aggressively developing our wholly-owned compounds and are reporting today additional Phase I findings with our huC242-DM4 anticancer agent, now in Phase II testing. |
| 2007-06-03 | AbbVie | Results ImmunoGen, Inc. Announces Clinical Data Reported at ASCO abbvie.com ↗
HuC242-DM4 has not been associated with dose-limiting toxicity in Phase I evaluation at doses expected to demonstrate activity in Phase II testing (abstract #3062). |
| 2006-11-08 | AbbVie | Results ImmunoGen, Inc. Announces Presentation of HuC242-DM4 Clinical Data at EORTC-NCI-AACR Conference abbvie.com ↗
ImmunoGen, Inc. (Nasdaq: IMGN) today announced the presentation of initial clinical data from an ongoing Phase I study evaluating the Company's huC242-DM4 compound for the treatment of colorectal, pancreatic, gastric and other CanAg-expressing cancers. |
| 2006-04-01 | AbbVie | Results ImmunoGen, Inc. Announces Eight Posters to be Presented at AACR on its TAP Technology and on Compounds in Development abbvie.com ↗
Findings from ImmunoGen's evaluation of alternative design options for its huC242-DM1 compound that demonstrate that the huC242-DM4 design provides the best activity across relevant tumor types (abstract #3727); |
| 2005-11-14 | AbbVie | Results ImmunoGen, Inc. Announces Clinical and Preclinical Findings with TAP Compounds to be Presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics abbvie.com ↗
The findings demonstrate that the antibody-drug linkage of huC242-DM4 is stable while the compound is circulating in the bloodstream. |
| 2005-04-17 | AbbVie | Results ImmunoGen, Inc. Reports Data at AACR on the Company's HuC242-DM4 Anticancer Compound abbvie.com ↗
In preclinical models, huC242-DM4 demonstrated potent anticancer activity directed against CanAg-expressing cancer cells - colon, pancreatic, gastric, lung - at doses that were well tolerated. |
| 2005-03-31 | AbbVie | Regulatory ImmunoGen, Inc. Files IND for its HuC242-DM4 Targeted Anticancer Compound abbvie.com ↗
ImmunoGen, Inc. (Nasdaq: IMGN) today announced that it has submitted an Investigational New Drug application (IND) to the US Food and Drug Administration (FDA) for its huC242-DM4 targeted anticancer therapeutic. |
All press releases naming this drug 11 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | CANTUZUMAB RAVTANSINE | ChEMBL registry synonym — accepted as the source's own label CHEMBL1742998 ↗ |
| Known as | Cantuzumab ravtansina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1742998 ↗ |
| Known as | HuC242-DM4 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00352131 ↗ |
| Known as | IMGN-242 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1742998 ↗ |
| Modality | Monoclonal antibody | “humanized monoclonal antibody huC242” NCT00352131 ↗ |
| Route | Intravenous | “Patients receive maytansinoid DM4-conjugated humanized monoclonal antibody huC242 IV over 4-5 hours on day 1.” NCT00352131 ↗ |
| Target | MUC1 | “Mucin-1 binding agent” CHEMBL1742998 ↗ |