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Inotuzumab ozogamicin | CAS No: 635715-01-4 | GMP-certified suppliers
A medication that treats relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukemia in adults by targeting malignant B cells to induce remission.
Therapeutic categories
Amino Acids, Peptides, and ProteinsAntibiotics, AntineoplasticAntibodiesAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntibody-drug Conjugates
Generic name
Inotuzumab ozogamicin
Molecule type
biotech
CAS number
635715-01-4
DrugBank ID
DB05889
Approval status
Approved drug, Investigational drug
ATC code
L01FB01
Primary indications
- Indicated as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL)
Product Snapshot
- Inotuzumab ozogamicin is a parenteral injectable formulation available as a lyophilized powder for intravenous administration
- Its primary therapeutic use is for the treatment of relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukemia (ALL)
- The product is approved for use in key regulatory markets including the US, Canada, and the European Union, with some investigational status remaining
Clinical Overview
Inotuzumab ozogamicin (CAS number 635715-01-4) is an antibody-drug conjugate indicated as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukemia (ALL). ALL is a rapidly progressing hematologic malignancy characterized by proliferation of immature B-cell lymphocytes, with limited therapeutic options following relapse or failure of prior treatments.
Pharmacologically, inotuzumab ozogamicin combines a recombinant humanized IgG4 kappa monoclonal antibody targeting the CD22 antigen, which is expressed on the surface of immature B cells, with a cytotoxic calicheamicin derivative, N-acetyl-gamma-calicheamicin dimethylhydrazide. The antibody specifically binds CD22, facilitating rapid internalization of the drug-antigen complex into the leukemic cells.
The mechanism of action involves intracellular release of the calicheamicin derivative within lysosomes under acidic conditions. This agent binds DNA in the minor groove at specific sequences, causing structural changes that lead to the generation of diradicals and subsequent DNA double-strand breaks. This induces apoptosis of malignant B cells, thereby inhibiting tumor growth and promoting remission.
Pharmacokinetic data indicate that inotuzumab ozogamicin acts as a targeted cytotoxic agent, with the antibody component conferring selectivity to CD22-positive cells, reducing systemic exposure to free calicheamicin. Clinically, QT interval prolongation has been observed and should be monitored during therapy.
Safety considerations include potential hepatotoxicity, myelosuppression, and infusion-related reactions. Close monitoring of liver function and blood counts is required. The drug exhibits a narrow therapeutic index and is a substrate of P-glycoprotein, factors that may influence drug interactions and toxicity.
Notable regulatory approvals include the European Union authorization in June 2017 and subsequent FDA approval in August 2017. The drug was co-developed by Pfizer and UCB. It is recognized within multiple drug categories, including monoclonal antibodies, antibody-drug conjugates, antineoplastic agents, and immunotherapies.
For pharmaceutical API sourcing, attention should be paid to stringent quality controls due to the complex nature of the antibody-drug conjugate, its sensitive linker chemistry, and the potent cytotoxic payload. Compliance with cGMP manufacturing standards, thorough characterization of conjugation efficiency, and rigorous impurity profiling are critical to ensure API consistency and safety in manufacturing.
Pharmacologically, inotuzumab ozogamicin combines a recombinant humanized IgG4 kappa monoclonal antibody targeting the CD22 antigen, which is expressed on the surface of immature B cells, with a cytotoxic calicheamicin derivative, N-acetyl-gamma-calicheamicin dimethylhydrazide. The antibody specifically binds CD22, facilitating rapid internalization of the drug-antigen complex into the leukemic cells.
The mechanism of action involves intracellular release of the calicheamicin derivative within lysosomes under acidic conditions. This agent binds DNA in the minor groove at specific sequences, causing structural changes that lead to the generation of diradicals and subsequent DNA double-strand breaks. This induces apoptosis of malignant B cells, thereby inhibiting tumor growth and promoting remission.
Pharmacokinetic data indicate that inotuzumab ozogamicin acts as a targeted cytotoxic agent, with the antibody component conferring selectivity to CD22-positive cells, reducing systemic exposure to free calicheamicin. Clinically, QT interval prolongation has been observed and should be monitored during therapy.
Safety considerations include potential hepatotoxicity, myelosuppression, and infusion-related reactions. Close monitoring of liver function and blood counts is required. The drug exhibits a narrow therapeutic index and is a substrate of P-glycoprotein, factors that may influence drug interactions and toxicity.
Notable regulatory approvals include the European Union authorization in June 2017 and subsequent FDA approval in August 2017. The drug was co-developed by Pfizer and UCB. It is recognized within multiple drug categories, including monoclonal antibodies, antibody-drug conjugates, antineoplastic agents, and immunotherapies.
For pharmaceutical API sourcing, attention should be paid to stringent quality controls due to the complex nature of the antibody-drug conjugate, its sensitive linker chemistry, and the potent cytotoxic payload. Compliance with cGMP manufacturing standards, thorough characterization of conjugation efficiency, and rigorous impurity profiling are critical to ensure API consistency and safety in manufacturing.
Identification & chemistry
| Generic name | Inotuzumab ozogamicin |
|---|---|
| Molecule type | Biotech |
| CAS | 635715-01-4 |
| UNII | P93RUU11P7 |
| DrugBank ID | DB05889 |
Pharmacology
| Summary | Inotuzumab ozogamicin is an antibody-drug conjugate targeting the CD22 antigen on B-cell precursors, delivering the cytotoxic agent N-acetyl-gamma-calicheamicin dimethylhydrazide intracellularly. Upon binding and internalization, the cytotoxic payload induces DNA double-strand breaks, leading to apoptosis in CD22-positive malignant B cells. This mechanism underlies its therapeutic intent in relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukemia. |
|---|---|
| Mechanism of action | Inotuzumab ozogamicin is comprised of cytotoxic antibiotic N-acetyl-gamma-calicheamicin dimethylhydrazide attached to a humanized monoclonal IgG4 antibody via 4-(4 acetylphenoxy) butanoic acid (acetyl butyrate) linker. The drug exerts a potent cytotoxic effect against CD22+ B-cell lymphoma when the antibody binds to the CD22 receptor on the surface of B cells . The drug-CD22 complex is rapidly internalized into the cell, forming an endosome which subsequently fuses with lysosomes. N-acetyl-gamma-calicheamicin dimethylhydrazide is then intracellularly released into the acidic environment. N-acetyl-gamma-calicheamicin dimethylhydrazide is a calicheamicin derivative, which is naturally produced by the bacterium Micromonospora echinospora, and is toxic to the body when not bound to the antibody. It mediates apoptosis of the cell by binding to the minor groove of DNA in a sequence-specific manner and undergoing a structural change to generate diradicals . These changes abstract hydrogen ions from the phosphodiester bonds of double-stranded DNA, resulting in breaks and cell apoptosis [A3883, A3884, A20352]. |
| Pharmacodynamics | Inotuzumab ozogamicin is an antineoplastic agent that targets CD22 antigen expressed on immature B-cell lymphocytes and blocks further growth of tumor cells. The drug aims to restore normal blood counts and achieve complete remission from the disease. QT interval prolongation was observed in patients receiving inotuzumab ozogamicin. |
Targets
| Target | Organism | Actions |
|---|---|---|
| B-cell receptor CD22 | Humans | antibody, regulator |
ADME / PK
| Absorption | Inotuzumab ozogamicin is intended to be administered in cycles that each run for 3 to 4 weeks. The steady state exposure of the drug is reached by Cycle 4. The mean (SD) maximum serum concentration (Cmax) of inotuzumab ozogamicin was 308 ng/mL (362) with patients receving the recommended dose of 1.8 mg/m^2/cycle . |
|---|---|
| Half-life | The elimination half life at the end of Cycle 4 of administration is approximately 12.3 days in a 2-compartment model . |
| Protein binding | *In vitro* studies show the binding of the N-acetyl-gamma-calicheamicin dimethylhydrazide to human plasma proteins to be approximately 97% . |
| Metabolism | N-acetyl-gamma-calicheamicin dimethylhydrazide primarily undergoes nonenzymatic reduction *in vitro*. The metabolism of N-acetyl-gamma-calicheamicin dimethylhydrazide in human serum is not clearly understood as the level of the drug is below the limit of quantification of 50 pg/mL . The antibody portion of the drug is thought to undergo proteolytic degradation into amino acids then recycled into other proteins . |
| Route of elimination | The drug is disposited in the body after administration. |
| Volume of distribution | The total volume of distribution of inotuzumab ozogamicin is approximately 12L . |
| Clearance | The clearance of inotuzumab ozogamicin at steady state is 0.0333 L/h . |
Formulation & handling
- Inotuzumab ozogamicin is a biotech-derived antibody-drug conjugate provided as a lyophilized powder for intravenous injection. The formulation requires reconstitution to a solution prior to parenteral administration. Handling should consider its biologic nature, necessitating protection from conditions that could degrade protein stability.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient's key patents have expired or are set to expire imminently across the US, Canada, and EU markets, marking its transition into a mature phase with established generic competition. Consequently, the API is widely available and utilized within these regions. |
|---|
| Markets | US, Canada, EU |
|---|
Supply Chain
| Supply chain summary | Inotuzumab ozogamicin is marketed under the branded product Besponsa across the US, Canada, and the EU, indicating a presence in major global markets. Originator companies hold the primary manufacturing role for this API. Given the existing branded presence, patent expiry timelines should be reviewed to assess the potential for current or forthcoming generic competition. |
|---|
Safety
| Toxicity | Inotuzumab ozogamicin was shown to be clastogenic *in vivo* in the bone marrow of male mice but was not mutagenic in an* in vitro* bacterial reverse mutation (Ames) assay. In rat toxicity studies, rats developed oval cell hyperplasia, altered hepatocellular foci, and hepatocellular adenomas however the carcinogenic potential of inotuzumab ozogamicin on humans is undetermined. Based on reproductive toxicity studies involving female rats and non-clinical studies, inotuzumab ozogamicin has the potential to impair reproductive function and fertility in men and women . |
|---|
High Level Warnings:
- Inotuzumab ozogamicin demonstrated clastogenic effects in vivo in bone marrow of male mice
- Mutagenicity was not observed in bacterial reverse mutation assays
- Toxicity studies in rats revealed liver alterations including oval cell hyperplasia, altered hepatocellular foci, and adenomas
Inotuzumab ozogamicin is a type of Antibacterials
Antibacterials, a category of pharmaceutical active pharmaceutical ingredients (APIs), play a crucial role in combating bacterial infections. These APIs are chemical compounds that target and inhibit the growth or kill bacteria, helping to eliminate harmful bacterial pathogens from the body.
Antibacterials are essential for the treatment of various bacterial infections, including respiratory tract infections, urinary tract infections, skin and soft tissue infections, and more. They are commonly prescribed by healthcare professionals to combat both mild and severe bacterial infections.
Within the category of antibacterials, there are different classes and subclasses of APIs, each with distinct mechanisms of action and target bacteria. Some commonly used antibacterials include penicillins, cephalosporins, tetracyclines, macrolides, and fluoroquinolones. These APIs work by interfering with various aspects of bacterial cellular processes, such as cell wall synthesis, protein synthesis, DNA replication, or enzyme activity.
The development and production of antibacterial APIs require stringent quality control measures to ensure their safety, efficacy, and purity. Pharmaceutical manufacturers must adhere to Good Manufacturing Practices (GMP) and follow rigorous testing protocols to guarantee the quality and consistency of these APIs.
As bacterial resistance to antibiotics continues to be a significant concern, ongoing research and development efforts aim to discover and develop new antibacterial APIs. The evolution of antibacterials plays a crucial role in combating emerging bacterial strains and ensuring effective treatment options for infectious diseases.
In summary, antibacterials are a vital category of pharmaceutical APIs used to treat bacterial infections. They are designed to inhibit or kill bacteria, and their development requires strict adherence to quality control standards. By continually advancing research in this field, scientists and pharmaceutical companies can contribute to the ongoing battle against bacterial infections.
