Drugs / Inotuzumab
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | acute lymphoblastic leukemia | 2017-02-21 | “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).” 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 ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT06533748 | Jan 2025 → May 2028 expected | lymphoblastic lymphoma, precursor B-cell acute lymphoblastic leukemia | St. Jude Children's Research Hospital | Recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT07443592 | Mar 2026 → Mar 2031 expected | acute lymphoblastic leukemia | PETHEMA Foundation | Not yet recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT03628053 Comparator | Jun 2020 → Oct 2025 | acute lymphoblastic leukemia | Novartis Pharmaceuticals | Withdrawn | No outcome recorded |
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 5 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Inotuzumab | “Resistant participants will receive a second induction with inotuzumab for B-cell precursor ALL or with FLAG-Ida (fludarabine, cytarabine, idarubicin and granulocyte colony...” NCT07443592 ↗ |
| Known as | G5/44 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297558 ↗ |
| Modality | Other / unclassified | “CD22-directed antibody-drug conjugate” NCT03628053 ↗ |
| Route | Intravenous | “2 doses of inotuzumab IV on Days 2 and 8” NCT06533748 ↗ |
| Target | CD22 | “CD22 binding agent” CHEMBL4297558 ↗ |