Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | MYLOTARG | — | 2020-06-16 | fda.gov ↗ |
| Approved | EU (EMA) | Mylotarg | — | 2018-04-19 | europa.eu ↗ |
| Approved | US (FDA) | MYLOTARG | — | 2017-09-01 | fda.gov ↗ |
| Refused (EMA) | EU (EMA) | Mylotarg | — | 2008-04-14 | europa.eu ↗ |
Trials 85 · started per year
Also used as a comparator or background therapy in 12 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03568994 Background | Jul 2018 → Sep 2020 | acute myeloid leukemia | Baylor College of Medicine | Completed | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT00577694 Background | Nov 2007 → Jul 2010 | leukemia | UNC Lineberger Comprehensive Cancer Center | Terminated | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT05564390 Comparator | Jun 2024 → May 2029 expected | acute myeloid leukemia with multilineage dysplasia, myelodysplastic syndrome, therapy related acute myeloid leukemia and myelodysplastic syndrome | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT05904106 Comparator | Apr 2024 → Sep 2028 expected | acute myeloid leukemia | Technical University Dresden | Recruiting | No outcome recorded |
| Phase 2 | NCT05955261 Background | Jul 2023 → Dec 2026 | acute myeloid leukemia | St. Jude Children's Research Hospital | Suspended | No outcome recorded |
| Phase 2 | NCT03589729 Background | Sep 2018 → Dec 2027 expected | Philadelphia-positive myelogenous leukemia, blast phase chronic myelogenous leukemia, BCR-ABL1 positive, myelodysplastic syndrome, myeloid sarcoma | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT00798213 Comparator | Jan 2009 → Apr 2010 | acute lymphoblastic leukemia, acute myeloid leukemia | Merck Sharp & Dohme LLC | Terminated | No outcome recorded |
| Phase 2 | NCT01039363 Background | — | acute myeloid leukemia | Samsung Medical Center | Unknown | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT02272478 Comparator | Oct 2014 → Feb 2021 | acute myeloid leukemia, myelodysplastic syndrome | Cardiff University | Unknown | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT05183035 Background | Oct 2022 → Feb 2027 expected | acute myeloid leukemia | PedAL BCU, LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT04293562 Background | Jul 2020 → Jun 2029 expected | acute myeloid leukemia | Children's Oncology Group | Recruiting | No outcome recorded |
| Phase 3 | NCT02665065 Comparator | Jun 2016 → Jun 2022 overdue | acute myeloid leukemia | Actinium Pharmaceuticals | Active not recruiting | No outcome recorded |
Press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2018-04-23 | Pfizer | MYLOTARG™ Approved In The EU For The Treatment Of Previously Untreated, De Novo, CD33-positive Acute Myeloid Leukemia In Combination With Chemotherapy pfizer.com ↗ |
| 2018-02-23 | Pfizer | Pfizer Receives Positive CHMP Opinion for Two Hematology Medicines, MYLOTARG™ and BOSULIF® pfizer.com ↗ |
| 2017-09-01 | Pfizer | Pfizer Receives FDA Approval for MYLOTARG™ (gemtuzumab ozogamicin) pfizer.com ↗ |
| 2017-07-11 | Pfizer | FDA Advisory Committee Votes in Favor of Pfizer’s MYLOTARG (gemtuzumab ozogamicin) for Acute Myeloid Leukemia pfizer.com ↗ |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 99 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Gemtuzumab-Ozogamicin | “We tested MCMs and standard statistical models using data from a clinical trial comparing gemtuzumab ozogamicin (GO) + standard chemotherapy against standard chemotherapy alone...” PMID 33858190 ↗ Apr 202190“Gemtuzumab Ozogamicin (GO) is a therapeutic CD33 antibody linked to a strong cytostatic drug (calicheamicin) which causes apoptosis of cancer cells upon internalization.” NCT04385290 ↗ “Gemtuzumab ozogamicin (GO) remained available to US clinicians through an open-label expanded-access protocol (NCT02312037) until GO was reapproved.” PMID 32432489 ↗ May 2020 “Upon HSC engraftment, patients will be treated with escalating doses of the anti-CD33 antibodydrug conjugate Gemtuzumab-Ozogamicin (GO).” NCT05662904 ↗ “Gemtuzumab ozogamicin (Mylotarg ®) is an immunoconjugate between anti-CD33 antibody and a cytotoxic antitumor antibiotic, calicheamicin.” NCT01698879 ↗ “GEMTUZUMAB OZOGAMICIN (Mylotarg): 5 mg, single dose 500 FS in 4 h - 6” NCT00909168 ↗ “Gemtuzumab ozogamicin (GO) 3 mg/m2 IV on day 1.” NCT00136084 ↗ “Mylotarg (gemtuzumab ozogamicin, or GO)” NCT02272478 ↗ “gemtuzumab ozogamicin” NCT04849910 ↗ “Gemtuzumab ozogamicin” NCT02665065 ↗ |
| Known as | CDP-771 | “CDP-771” NCT00801489 ↗ |
| Known as | CMA-676 | “Gemtuzumab Ozogamicin (CMA-676) is a chemotherapeutic agent consisting of a recombinant humanized anti-CD33 antibody conjugated with calicheamicin, a highly potent cytotoxic...” NCT01020539 ↗3“Gemtuzumab Ozogamicin (CMA-676) is a chemotherapeutic agent consisting of recombinant humanized anti-CD33 antibody conjugated with calicheamicin, a highly potent cytotoxic...” NCT00669890 ↗ “A Dose Escalation And Phase II Study Of Gemtuzumab Ozogamicin (CMA-676; Mylotarg) With High-Dose Cytarabine For Patients With Refractory Or Relapsed Acute Myeloid Leukemia (AML)” NCT00006265 ↗ “gemtuzumab ozogamicin (CMA-676) with or without mitoxantrone, etoposide, cytarabine, and idarubicin in elderly patients with acute myeloid leukemia.” NCT00006122 ↗ |
| Known as | gemtuzumab | “Gemtuzumab ozogamicin is a monoclonal antibody, called gemtuzumab, linked to a antitumor drug, called calicheamicin” NCT00801489 ↗1“Gemtuzumab (GO) added to the standard induction regimen of 7 days of Ara-C and 3 days of daunomycin” NCT00085709 ↗ |
| Known as | GTMZ | “While gemtuzumab ozogamicin (GTMZ) is commonly used in the treatment of acute myeloid leukemia (AML) in combination with standard chemotherapy agents” PMID 18467731 ↗ May 2008 |
| Known as | Mylotarg | “Phase II Study of Genasense (Bcl-2 Antisense) Combined With Mylotarg (Gemtuzumab Ozogamicin) in Elderly Patients With Relapsed Acute Myeloid Leukemia” NCT00017589 ↗14“GEMTUZUMAB OZOGAMICIN (MYLOTARG (TRADEMARKER)) AS A SINGLE-AGENT REGIMEN” NCT03727750 ↗ “GEMTUZUMAB OZOGAMICIN (Mylotarg): 5 mg, single dose 500 FS in 4 h - 6” NCT00909168 ↗ “Mylotarg (gemtuzumab ozogamicin) Injection” NCT00044733 ↗ “Gemtuzumab Ozogamicin (Mylotarg)” NCT00893399 ↗ |
| Known as | Mylotarg (GO) | “Mylotarg (GO)” NCT02272478 ↗ |
| Action | Deplete | “can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells” NCT00049179 ↗ |
| Modality | Monoclonal antibody | “anti-CD33 monoclonal antibody” PMID 30062662 ↗ Mar 2019 |
| Route | Intravenous | “Arm I: Patients receive cytarabine IV over 2 hours on days 1-4 and gemtuzumab ozogamicin IV over 2 hours on day 5.” NCT00005962 ↗ |
| Target | CD33 | “anti-CD33 monoclonal antibody” PMID 30062662 ↗ Mar 2019 |