Inotuzumab Ozogamicin
Monoclonal antibody targets CD22
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed acute lymphoblastic leukemia 2 milestones | |||||
| Filed | US (FDA) | — | acute lymphoblastic leukemia | 2017-02-21 | “a Biologics License Application (BLA) for inotuzumab ozogamicin has been accepted for filing” pfizer.com ↗ |
| Filed | EU (EMA) | — | acute lymphoblastic leukemia | — | “a Marketing Authorization Application (MAA) for inotuzumab ozogamicin in the same patient population is currently under review by the European Medicines Agency (EMA)” pfizer.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansion | US (FDA) | BESPONSA | — | 2024-03-06 | fda.gov ↗ |
| Approved | US (FDA) | BESPONSA | — | 2017-08-17 | fda.gov ↗ |
| Approved | EU (EMA) | Besponsa | — | 2017-06-28 | europa.eu ↗ |
Trials 60
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2017-08-17 | Pfizer | Regulatory Pfizer Receives U.S. FDA Approval for BESPONSA® (inotuzumab ozogamicin) pfizer.com ↗
Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved BESPONSA® (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). |
| 2017-06-30 | Pfizer | Regulatory BESPONSA® Approved in the EU for Adult Patients with Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia pfizer.com ↗
Pfizer Inc. (NYSE:PFE) today announced that the European Commission has approved BESPONSA® (inotuzumab ozogamicin) as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL). |
| 2017-04-21 | Pfizer | Regulatory Pfizer Receives Positive CHMP Opinion for BESPONSA® (Inotuzumab Ozogamicin) for the Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia pfizer.com ↗ |
| 2017-02-21 | Pfizer | Regulatory Pfizer Announces Acceptance of Regulatory Submission for Inotuzumab Ozogamicin by the U.S. Food and Drug Administration pfizer.com ↗
Pfizer Inc. (NYSE:PFE) today announced that a Biologics License Application (BLA) for inotuzumab ozogamicin has been accepted for filing and granted Priority Review by the U.S. Food and Drug Administration (FDA). |
| 2016-06-12 | Pfizer | Results Pfizer Announces Final Results from Inotuzumab Ozogamicin Pivotal Phase 3 Study in Adults with Relapsed/Refractory Acute Lymphoblastic Leukemia pfizer.com ↗
Results showed improvement over chemotherapy on a number of measures including complete hematologic remission and progression-free survival (PFS). |
| 2015-10-19 | Pfizer | Regulatory Pfizer’s Inotuzumab Ozogamicin Receives FDA Breakthrough Therapy Designation for Acute Lymphoblastic Leukemia (ALL) pfizer.com ↗
Pfizer Inc. today announced that investigational antibody-drug conjugate (ADC) inotuzumab ozogamicin received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for acute lymphoblastic leukemia (ALL). |
| 2015-04-21 | Pfizer | Results Pfizer Phase 3 Study Of Inotuzumab Ozogamicin Meets Primary Endpoint In Adult Patients With Relapsed Or Refractory Acute Lymphoblastic Leukemia pfizer.com ↗ |
All press releases naming this drug 7 releases
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 71 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Inotuzumab Ozogamicin | “First-Line Consolidation Chemotherapy with Olverembatinib + Inotuzumab Ozogamicin Olverembatinib: 40 mg every other day (QOD), from day 1 to day 28.” NCT07443488 ↗60“Immunotherapies includes CD19-directed CD3 T-cell engager, inotuzumab ozogamicin (INO) and CD22/CD19 CAR-T cell.” NCT06985498 ↗ “Inotuzumab ozogamicin, venetoclax, vincristine, and prednisone.” NCT07495631 ↗ |
| Known as | BESPONSA | “Inotuzumab ozogamicin (BESPONSA™) is a CD22 targeted antibody drug conjugate (ADC) approved by US FDA for treatment of adults with relapsed or refractory B cell precursor acute...” NCT03677596 ↗1“two 3- week cycles of Inotuzumab ozogamicin (InO) - Besponsa®.” NCT04307576 ↗ |
| Known as | CMC-544 | “Inotuzumab ozogamicin (CMC-544), an antibody-targeted chemotherapeutic agent composed of an anti-CD22 antibody conjugated to calicheamicin, a potent cytotoxic antibiotic,...” PMID 20491780 ↗ Apr 20105“Inotuzumab Ozogamicin (CMC-544), a humanized anti-CD22 antibody conjugated to the potent cytotoxic antibiotic calicheamicin, targets the CD22 antigen expressed on the majority...” PMID 22335424 ↗ Mar 2012 “Inotuzumab ozogamicin (PF-05208773; CMC-544) is an antibody-targeted intravenous (IV) chemotherapy agent composed of an anti-CD22 antibody linked to calicheamicin, a potent...” NCT03460522 ↗ “Inotuzumab Ozogamicin (CMC-544)” NCT00868608 ↗ |
| Known as | InO | “Objective: To evaluate safety, tolerability, and preliminary activity of inotuzumab ozogamicin (InO) plus rituximab, gemcitabine, dexamethasone, and cisplatin (R-GDP) in...” PMID 28959500 ↗ Aug 20179“Inotuzumab ozogamicin (InO), a humanized anti-CD22 monoclonal antibody conjugated to the cytotoxic antibiotic agent calicheamicin, has demonstrated efficacy in the phase 3...” PMID 29330398 ↗ Jan 2018 “Among ADCs, inotuzumab ozogamicin (InO) has proven effective as monotherapy for relapsed disease, leading to FDA approval for patients aged >1 year with relapsed/refractory B-ALL.” PMID 41671463 ↗ Dec 2025 “The efficacy of inotuzumab ozogamicin (InO), a humanized anti-CD22 monoclonal antibody conjugated to the cytotoxic antibiotic calicheamicin, was evaluated in R/R ALL patients” PMID 33231879 ↗ Nov 2020 “Inotuzumab ozogamicin (InO) is a CD22-targeted monoclonal antibody conjugated to the cytotoxic antibiotic calicheamicin.” NCT06861348 ↗ “Immunotherapies includes CD19-directed CD3 T-cell engager, inotuzumab ozogamicin (INO) and CD22/CD19 CAR-T cell.” NCT06985498 ↗ “Inotuzumab ozogamicin (InO) is an antibody-drug conjugate that delivers calicheamicin to CD22-expressing cells.” PMID 38551807 ↗ Jul 2024 “two 3- week cycles of Inotuzumab ozogamicin (InO) - Besponsa®.” NCT04307576 ↗ “Drug: Inotuzumab ozogamicin (INO)” NCT03249870 ↗ “Drug: Inotuzumab ozogamicin (INO)” NCT07476729 ↗ |
| Known as | inotuzumab | “Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called N-acetyl-gamma-calicheamicin dimethyl hydrazide (CalichDMH).” NCT01371630 ↗5“Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a chemotherapy drug called ozogamicin.” NCT03150693 ↗ “Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a chemotherapy drug called ozogamicin.” NCT03856216 ↗ “Inotuzumab ozogamicin (InO) is an antibody-drug conjugate that delivers calicheamicin to CD22-expressing cells.” PMID 38551807 ↗ Jul 2024 “Inotuzumab Ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called ozogamicin.” NCT03094611 ↗ “Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a drug, called CalichDMH.” NCT05303792 ↗ |
| Known as | inotuzumab ozogamycin | “Determine the maximum tolerated dose (MTD) of inotuzumab ozogamicin (inotuzumab ozogamycin) in combination with low-intensity chemotherapy in elderly patients (age 60 or older)...” NCT01371630 ↗1“CMC-544 (Inotuzumab Ozogamycin)” NCT01134575 ↗ |
| Known as | NSC# 772518 | “A Phase 2 Study of Inotuzumab Ozogamicin (NSC# 772518) in Children and Young Adults With Relapsed or Refractory CD22+ B-Acute Lymphoblastic Leukemia (B-ALL)” NCT02981628 ↗ |
| Known as | PF-05208773 | “Inotuzumab ozogamicin (PF-05208773; CMC-544) is an antibody-targeted intravenous (IV) chemotherapy agent composed of an anti-CD22 antibody linked to calicheamicin, a potent...” NCT03460522 ↗ |
| Action | Deplete | “This may cause the cancer cells to die.” NCT01134575 ↗ |
| Modality | Monoclonal antibody | “Inotuzumab ozogamicin (INO) is an antibody-targeted chemotherapy agent composed of a humanized anti-CD22 antibody conjugated to calicheamicin, a potent cytotoxic agent.” PMID 23295790 ↗ Jan 2013 |
| Route | Intravenous | “CMC-544, IV, dose escalation trial” NCT00073749 ↗ |
| Target | CD22 | “Inotuzumab ozogamicin (INO) is an antibody-targeted chemotherapy agent composed of a humanized anti-CD22 antibody conjugated to calicheamicin, a potent cytotoxic agent.” PMID 23295790 ↗ Jan 2013 |