Gemtuzumab Ozogamicin

also known as Mylotarg · CMA-676 · gemtuzumab · CDP-771 · GTMZ · Mylotarg (GO)

Developed for: acute myeloid leukemia · leukemia · myelodysplastic syndrome · acute promyelocytic leukemia · acute myeloid leukemia with 11q23 abnormalities · acute myeloid leukemia with abnormal bone marrow eosinophils inv(16)(p13q22) or t(16;16)(p13;q22) · acute myeloid leukemia with t(8;21)(q22;q22) translocation · acute megakaryoblastic leukemia in adult
+18 more
· acute myeloblastic leukemia with maturation · acute myeloblastic leukemia without maturation · acute myeloid leukemia, inv(16)(p13.1;q22) · acute myeloid leukemia, t(16;16)(p13.1;q22) · acute myelomonocytic leukemia M4 · adult acute monocytic leukemia · acute myeloid leukemia with minimal differentiation · acute myeloid leukemia, t(8;21)(q22; q22.1) · childhood acute myeloid leukemia · erythroleukemia · juvenile myelomonocytic leukemia · acute erythroid leukemia · acute myeloid leukemia, t(9;11)(p21.3;q23.3) · chronic lymphocytic leukemia/small lymphocytic lymphoma · core binding factor acute myeloid leukemia · myelodysplastic syndrome with excess blasts · myeloid leukemia · acute myeloid leukemia with multilineage dysplasia
Investigated by: National Cancer Institute (NCI) · Pfizer · M.D. Anderson Cancer Center · Wyeth is now a wholly owned subsidiary of Pfizer · European Organisation for Research and Treatment of Cancer - EORTC · Fred Hutchinson Cancer Center
+57 more
· Children's Oncology Group · GIMEMA Foundation · Jazz Pharmaceuticals · New York Medical College · SWOG Cancer Research Network · University Hospital Heidelberg · Acute Leukemia French Association · Eastern Cooperative Oncology Group · Jonsson Comprehensive Cancer Center · University of Ulm · Versailles Hospital · Wake Forest University Health Sciences · Weill Medical College of Cornell University · AbbVie · Alliance for Clinical Trials in Oncology · Assistance Publique - Hôpitaux de Paris · Brown University · Cancer Research UK · Celgene Corporation · Columbia University · Eisai Inc. · Emory University · Genta Incorporated · German Cancer Research Center · H. Lee Moffitt Cancer Center and Research Institute · HOVON Foundation · Hematologics, Inc · Italian Association of Pediatric Hematology and Oncology · John Quigley · Kanisa Pharmaceuticals · Medical College of Wisconsin · National Cancer Institute, France · National Center for Tumor Diseases, Heidelberg · Novartis Pharmaceuticals · Rhode Island Hospital · Robert Redner, MD · Roswell Park Cancer Institute · Shaare Zedek Medical Center · Spanish Cooperative Group for the Study and Treatment of Acute Leukemias and Myelodysplasias · St. Jude Children's Research Hospital · Technical University Dresden · The Cleveland Clinic · The Miriam Hospital · The University of New South Wales · Uma Borate · University Hospital Carl Gustav Carus · University Hospital Dresden · University Hospital, Udine, Italy · University of Aarhus · University of Birmingham · University of California, Los Angeles · University of California, San Diego · University of Maryland, Baltimore · University of Michigan · University of Pittsburgh · University of Washington · Vor Biopharma

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

today

US approved 2017

EU approved 2018

199719981999200020012002200320042005200620072008200920102011201220132014201520162017201820192020202120222023202420252026202720282029

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 113 trials
Phase 1	NCT05662904	Jan 2028 → Jan 2029 expected	acute myeloid leukemia	German Cancer Research Center	Not yet recruiting	No outcome recorded
Phase 1	NCT05558124	Feb 2023 → Apr 2027 expected	acute myeloid leukemia	H. Lee Moffitt Cancer Center and Research Institute	Recruiting	No outcome recorded
Phase 1	NCT04915612	May 2021 → Jan 2025	acute myeloid leukemia	M.D. Anderson Cancer Center	Completed	No outcome recorded
Phase 1	NCT04207190	Oct 2020 → May 2024	acute myeloid leukemia	Roswell Park Cancer Institute	Completed	No outcome recorded
Phase 1	NCT04070768	Sep 2019 → Oct 2023	acute myeloid leukemia	John Quigley	Completed	No outcome recorded
Phase 1	NCT03878927	Aug 2019 → Aug 2022	acute myeloid leukemia	Weill Medical College of Cornell University	Terminated	No outcome recorded
Phase 1	NCT03904251	Jul 2019 → Oct 2023	acute myeloid leukemia	Jonsson Comprehensive Cancer Center	Terminated	No outcome recorded Stop: Enrollment
Phase 1	NCT03848754	May 2019 → May 2021	acute myeloid leukemia	Medical College of Wisconsin	Completed	No outcome recorded
Phase 1	NCT03900949	Mar 2019 → Aug 2024	acute myeloid leukemia	Uma Borate	Completed	No outcome recorded
Phase 1	NCT00660036	Sep 2008 → Apr 2011	acute myeloid leukemia	University of Pittsburgh	Terminated	No outcome recorded
Phase 1	NCT00669890	May 2004 → Dec 2012	acute myeloid leukemia, juvenile myelomonocytic leukemia, myelodysplastic syndrome	New York Medical College	Terminated	No outcome recorded
Phase 1	NCT01020539	Sep 2002 → Jul 2011	acute myeloid leukemia, juvenile myelomonocytic leukemia, myelodysplastic syndrome	Columbia University	Completed	No outcome recorded
Phase 1	NCT00028899	Jul 2002 → Sep 2006	leukemia, myelodysplastic syndrome	Children's Oncology Group	Completed	No outcome recorded

Phase 1/210 trials · 1 met primary
Phase 1/2	NCT04849910	Dec 2021 → May 2025	acute myeloid leukemia, myelodysplastic syndrome	Vor Biopharma	Terminated	Met primary Stop: Business
Phase 1/2	NCT04385290	Sep 2020 → Apr 2027 expected	acute myeloid leukemia	Technical University Dresden	Recruiting	No outcome recorded
Phase 1/2	NCT03531918	Sep 2018 → Jul 2021	acute myeloid leukemia	Fred Hutchinson Cancer Center	Completed	No outcome recorded
Phase 1/2	NCT03390296	Dec 2017 → Feb 2022	acute myeloid leukemia	M.D. Anderson Cancer Center	Completed	No outcome recorded
Phase 1/2	NCT00895934	May 2009 → Jul 2013	acute megakaryoblastic leukemia in adult, acute myeloblastic leukemia with maturation, acute myeloblastic leukemia without maturation, acute myeloid leukemia with 11q23 abnormalities +6	National Cancer Institute (NCI)	Completed	No outcome recorded
Phase 1/2	NCT02182596	Jun 2006 → Sep 2007	acute myeloid leukemia	Acute Leukemia French Association	Completed	No outcome recorded
Phase 1/2	NCT00233909	Oct 2005 → Mar 2008	myeloid leukemia	Kanisa Pharmaceuticals	Completed	No outcome recorded
Phase 1/2	NCT00766116	Jul 2005 → Sep 2014	acute myeloid leukemia	University of California, San Diego	Completed	No outcome recorded
Phase 1/2	NCT00460447	Oct 2004 → ?	acute myeloid leukemia	University Hospital Carl Gustav Carus	Unknown	No outcome recorded
Phase 1/2	NCT00038831	May 2001 → Mar 2005	acute myeloid leukemia, chronic lymphocytic leukemia/small lymphocytic lymphoma, myelodysplastic syndrome	M.D. Anderson Cancer Center	Completed	No outcome recorded
Phase 240 trials · 1 missed
Phase 2	NCT06917911	Sep 2026 → Nov 2027 expected	core binding factor acute myeloid leukemia	National Cancer Institute (NCI)	Recruiting	No outcome recorded
Phase 2	NCT05599360	Aug 2022 → Oct 2023 overdue	acute myeloid leukemia	Shaare Zedek Medical Center	Active not recruiting	No outcome recorded
Phase 2	NCT04326439	Jan 2020 → Mar 2022	childhood acute myeloid leukemia	Emory University	Terminated	No outcome recorded Stop: Enrollment
Phase 2	NCT03374332	Dec 2019 → Sep 2023 overdue	acute myeloid leukemia	Brown University	Active not recruiting	No outcome recorded
Phase 2	NCT04050280	Nov 2019 → Jun 2027 expected	acute myeloid leukemia	University of Maryland, Baltimore	Recruiting	No outcome recorded
Phase 2	NCT04173585	Oct 2019 → Feb 2023	acute myeloid leukemia	University Hospital Heidelberg	Completed	No outcome recorded
Phase 2	NCT04793919	Oct 2019 → Oct 2025 overdue	acute promyelocytic leukemia	Italian Association of Pediatric Hematology and Oncology	Recruiting	No outcome recorded
Phase 2	NCT03839446	Feb 2019 → Feb 2023	acute myeloid leukemia	Robert Redner, MD	Completed	No outcome recorded
Phase 2	NCT03737955	Nov 2018 → Dec 2026 expected	acute myeloid leukemia	University of Washington	Recruiting	No outcome recorded
Phase 2	NCT03672539	Nov 2018 → Nov 2027 expected	acute myeloid leukemia, chronic myelomonocytic leukemia, myelodysplastic syndrome	M.D. Anderson Cancer Center	Active not recruiting	No outcome recorded
Phase 2	NCT01548911	May 2012 → Sep 2013	acute myeloid leukemia with 11q23 abnormalities, acute myeloid leukemia with abnormal bone marrow eosinophils inv(16)(p13q22) or t(16;16)(p13;q22), acute myeloid leukemia with t(8;21)(q22;q22) translocation, acute myeloid leukemia, inv(16)(p13.1;q22) +1	Wake Forest University Health Sciences	Withdrawn	No outcome recorded
Phase 2	NCT02117297	Jan 2012 → Mar 2023	acute myeloid leukemia, myelodysplastic syndrome	New York Medical College	Completed	No outcome recorded
Phase 2	NCT02221310	Dec 2011 → Apr 2023	acute myeloid leukemia, myelodysplastic syndrome	New York Medical College	Completed	No outcome recorded
Phase 2	NCT01409161	Oct 2011 → Dec 2027 expected	acute promyelocytic leukemia	M.D. Anderson Cancer Center	Recruiting	No outcome recorded
Phase 2	NCT01698879	Oct 2009 → Sep 2016	acute myeloid leukemia	Spanish Cooperative Group for the Study and Treatment of Acute Leukemias and Myelodysplasias	Completed	No outcome recorded
Phase 2	NCT00882102	Apr 2009 → Aug 2012	acute myeloid leukemia, myelodysplastic syndrome	M.D. Anderson Cancer Center	Completed	No outcome recorded
Phase 2	NCT00658814	Dec 2008 → Jun 2013 overdue	acute megakaryoblastic leukemia in adult, acute myeloblastic leukemia with maturation, acute myeloblastic leukemia without maturation, acute myeloid leukemia, inv(16)(p13.1;q22) +6	National Cancer Institute (NCI)	Active not recruiting	No outcome recorded
Phase 2	NCT00673153	Mar 2008 → Aug 2010	acute erythroid leukemia, acute megakaryoblastic leukemia in adult, acute myeloblastic leukemia with maturation, acute myeloblastic leukemia without maturation +7	Fred Hutchinson Cancer Center	Terminated	No outcome recorded
Phase 2	NCT00968071	Feb 2008 → Aug 2012	acute myeloid leukemia, myelodysplastic syndrome	M.D. Anderson Cancer Center	Completed	No outcome recorded
Phase 2	NCT00551460	Nov 2007 → Jun 2017	leukemia	SWOG Cancer Research Network	Completed	No outcome recorded
Phase 2	NCT00801489	Apr 2007 → Oct 2028 expected	acute myeloid leukemia, inv(16)(p13.1;q22), acute myeloid leukemia, t(16;16)(p13.1;q22), acute myeloid leukemia, t(8;21)(q22; q22.1), myelodysplastic syndrome with excess blasts	M.D. Anderson Cancer Center	Recruiting	No outcome recorded
Phase 2	NCT00413166	Dec 2006 → Feb 2016	acute promyelocytic leukemia	M.D. Anderson Cancer Center	Completed	No outcome recorded
Phase 2	NCT00143975	Jun 2004 → Jul 2007	acute myeloid leukemia	University of Ulm	Completed	No outcome recorded
Phase 2	NCT00089050	May 2004 → Mar 2006	leukemia	Fred Hutchinson Cancer Center	Completed	No outcome recorded
Phase 2	NCT00274781	Feb 2004 → Dec 2008	leukemia, myelodysplastic syndrome	The Cleveland Clinic	Completed	No outcome recorded
Phase 2	NCT00070174	Dec 2003 → Sep 2006	leukemia	Children's Oncology Group	Completed	No outcome recorded
Phase 2	NCT00077116	Nov 2003 → Nov 2006	leukemia, myelodysplastic syndrome	European Organisation for Research and Treatment of Cancer - EORTC	Completed	No outcome recorded
Phase 2	NCT00195000	May 2003 → May 2006	acute myeloid leukemia, myelodysplastic syndrome	Weill Medical College of Cornell University	Completed	No outcome recorded
Phase 2	NCT00049179	Apr 2003 → Dec 2005	leukemia	SWOG Cancer Research Network	Completed	No outcome recorded
Phase 2	NCT00022321	Sep 2001 → ?	myelodysplastic syndrome	Jonsson Comprehensive Cancer Center	Unknown	No outcome recorded
Phase 2	NCT00006265	Mar 2001 → Dec 2004	leukemia	Alliance for Clinical Trials in Oncology	Completed	No outcome recorded
Phase 2	NCT00017589	Dec 2000 → May 2006	leukemia	Genta Incorporated	Completed	No outcome recorded
Phase 2	NCT00005962	Oct 2000 → Oct 2005	leukemia	Eastern Cooperative Oncology Group	Completed	Missed primary
Phase 2	NCT00008151	Oct 2000 → Jul 2002	leukemia, myelodysplastic syndrome	Fred Hutchinson Cancer Center	Completed	No outcome recorded
Phase 2	NCT00037596	Aug 2000 → Apr 2003	acute myeloid leukemia	Wyeth is now a wholly owned subsidiary of Pfizer	Completed	No outcome recorded
Phase 2	NCT00006122	Jun 2000 → Jan 2002	leukemia	European Organisation for Research and Treatment of Cancer - EORTC	Completed	No outcome recorded
Phase 2	NCT00044733	Mar 2000 → Sep 2004	acute myeloid leukemia	Wyeth is now a wholly owned subsidiary of Pfizer	Completed	No outcome recorded
Phase 2	NCT00003673	Mar 1998 → Mar 1999	leukemia	Pfizer	Completed	No outcome recorded
Phase 2	NCT00003131	Feb 1997 → Feb 2002	leukemia	Pfizer	Completed	No outcome recorded
Phase 2	NCT00037583	? → Sep 2003	acute myeloid leukemia	Wyeth is now a wholly owned subsidiary of Pfizer	Completed	No outcome recorded

Phase 2/35 trials · 1 met primary
Phase 2/3	NCT02473146	Nov 2015 → Feb 2021	acute myeloid leukemia	Versailles Hospital	Completed	No outcome recorded
Phase 2/3	NCT00909168	Mar 2008 → May 2009	acute myeloid leukemia	University Hospital, Udine, Italy	Completed	No outcome recorded
Phase 2/3	NCT00454480	Aug 2006 → Aug 2012	leukemia, myelodysplastic syndrome	The University of New South Wales	Completed	No outcome recorded
Phase 2/3	NCT00091234	Jun 2004 → Dec 2013	leukemia	European Organisation for Research and Treatment of Cancer - EORTC	Unknown	Met primary
Phase 2/3	NCT00038805	May 2001 → Nov 2004	leukemia	M.D. Anderson Cancer Center	Terminated	No outcome recorded
Phase 313 trials · 1 met primary · 4 missed
Phase 3	NCT04093505	Apr 2021 → Jun 2022	acute myeloid leukemia	University Hospital Heidelberg	Terminated	No outcome recorded Stop: Enrollment
Phase 3	NCT04168502	Sep 2020 → Apr 2025 overdue	acute myeloid leukemia	GIMEMA Foundation	Recruiting	No outcome recorded
Phase 3	NCT02724163	Apr 2016 → Dec 2031 expected	acute myeloid leukemia	University of Birmingham	Active not recruiting	No outcome recorded
Phase 3	NCT00893399	May 2010 → Sep 2021	acute myeloid leukemia	University of Ulm	Completed	Missed primary
Phase 3	NCT00927498	Dec 2007 → Jul 2011	acute myeloid leukemia	Acute Leukemia French Association	Completed	No outcome recorded
Phase 3	NCT00372593	Aug 2006 → Aug 2013	leukemia	Children's Oncology Group	Completed	Mixed
Phase 3	NCT00121303	Jan 2005 → Jan 2009	leukemia, myelodysplastic syndrome	HOVON Foundation	Completed	No outcome recorded
Phase 3	NCT00085709	Jul 2004 → Mar 2010	leukemia	SWOG Cancer Research Network	Completed	Missed primary
Phase 3	NCT00476541	Jan 2004 → Jan 2012	acute myeloid leukemia	University of Aarhus	Completed	No outcome recorded
Phase 3	NCT00049517	Dec 2002 → Mar 2009	leukemia	Eastern Cooperative Oncology Group	Completed	Met primary
Phase 3	NCT00052299	Sep 2002 → Jan 2008	leukemia	European Organisation for Research and Treatment of Cancer - EORTC	Completed	Missed primary
Phase 3	NCT00136084	Aug 2002 → Jul 2008	acute myeloid leukemia	St. Jude Children's Research Hospital	Completed	Missed primary
Phase 3	NCT00962767	May 2002 → Dec 2007	acute myeloid leukemia	Wyeth is now a wholly owned subsidiary of Pfizer	Completed	No outcome recorded

Phase 42 trials
Phase 4	NCT03727750	Jul 2019 → Apr 2021	—	Pfizer	Completed	No outcome recorded
Phase 4	NCT00304447	Apr 2002 → Jan 2004	acute myeloid leukemia	Wyeth is now a wholly owned subsidiary of Pfizer	Completed	No outcome recorded
Phase not stated2 trials
—	NCT02312037	—	acute myeloid leukemia	Pfizer	No longer available	No outcome recorded
—	NCT01869803	—	acute myeloid leukemia with 11q23 abnormalities, acute myeloid leukemia with abnormal bone marrow eosinophils inv(16)(p13q22) or t(16;16)(p13;q22), acute myeloid leukemia with t(8;21)(q22;q22) translocation, acute promyelocytic leukemia +1	Wake Forest University Health Sciences	Approved for marketing	No outcome recorded
Comparator or background therapy12 trials
Phase 0	NCT03568994 Background	Jul 2018 → Sep 2020	acute myeloid leukemia	Baylor College of Medicine	Completed	No outcome recorded
Phase 1	NCT00577694 Background	Nov 2007 → Jul 2010	leukemia	UNC Lineberger Comprehensive Cancer Center	Terminated	No outcome recorded Stop: Business
Phase 2	NCT05564390 Comparator	Jun 2024 → May 2029 expected	acute myeloid leukemia with multilineage dysplasia, 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 expected	acute myeloid leukemia	St. Jude Children's Research Hospital	Recruiting	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 2/3	NCT02272478 Comparator	Oct 2014 → Feb 2021	acute myeloid leukemia, myelodysplastic syndrome	Cardiff University	Unknown	No outcome recorded
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	Met primary

News releases announcing trial results or a regulatory action · 5

Date	Issuer	Release
2022-12-07	PureTech	Results PureTech Founded Entity Vor Bio Announces First AML Patient Successfully Transplanted with its Investigational Trem-cel (VOR33) and Tolerated Mylotarg™ puretechhealth.com ↗ The data observed from the first treated patient support the potential of a trem-cel transplant to be successfully manufactured, to engraft normally, and to maintain blood counts following treatment with the CD33-targeted therapy Mylotarg.
2018-04-23	Pfizer	Regulatory 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	Regulatory Pfizer Receives Positive CHMP Opinion for Two Hematology Medicines, MYLOTARG™ and BOSULIF® pfizer.com ↗ MYLOTARG™ (gemtuzumab ozogamicin) in combination with daunorubicin and cytarabine has been granted a positive opinion for the treatment of patients age 15 years and above with previously untreated, de novo, CD33-positive acute myeloid leukemia (AML), except acute promyelocytic leukemia (APL).
2017-09-01	Pfizer	Regulatory Pfizer Receives FDA Approval for MYLOTARG™ (gemtuzumab ozogamicin) pfizer.com ↗ Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration approved MYLOTARG™ (gemtuzumab ozogamicin) for adults with newly diagnosed CD33-positive acute myeloid leukemia (AML), and adults and children 2 years and older with relapsed or refractory CD33-positive AML.
2017-07-11	Pfizer	Regulatory FDA Advisory Committee Votes in Favor of Pfizer’s MYLOTARG (gemtuzumab ozogamicin) for Acute Myeloid Leukemia pfizer.com ↗ Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration’s (FDA) Oncologic Drug Advisory Committee (ODAC) voted that the results of ALFA-0701 demonstrated a favorable risk:benefit profile for MYLOTARG (gemtuzumab ozogamicin) 3 mg/m 2 on days 1, 4 and 7 added to chemotherapy for patients with newly-diagnosed CD33-positive acute myeloid leukemia (AML).

All press releases naming this drug 5 releases

Date	Issuer	Release
2022-12-07	PureTech	PureTech Founded Entity Vor Bio Announces First AML Patient Successfully Transplanted with its Investigational Trem-cel (VOR33) and Tolerated Mylotarg™ puretechhealth.com ↗
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 2021 90 “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 ↗ NCT00660036 ↗ Show 80 more sources
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 ↗ NCT00038831 ↗ NCT00304447 ↗ NCT04793919 ↗ NCT00038805 ↗ NCT00195000 ↗ NCT05599360 ↗ Show 4 more sources
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